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Plan and lead the quality control routine operations and stability studies and drive the team to confirm testing as per the GLP guidelines and regulatory requirements and achieve timely release of batches and SRB targets to meet unit OTIF.

Key Accountabilities

I. Plan the quality control routine operations and stability studies to ensure timely completion of stability studies and smooth functioning of release activity

• Monitor the commitment dates for release of RM, PM, FP & water analysis and process/cleaning validation section by conducting performance dialogues and handshake

• Review the plans prepared and monitor timely execution of activities in all the shifts to avoid delays

• Review the monthly planner and production plans to ensure timely availability of required resources and ensure no sample is overdue

II. Monitor the execution of all routine quality control operation and stability studies to ensure timely delivery and meet regulatory requirements and cGMP, GLP guidelines

• Monitor routine/stability operations closely and ensure that all necessary SOPs are followed by the team

• Provide technical guidance related to troubleshooting in chromatography, experimentation design etc. to minimize non-conformances

• Monitor timely implementation of new updates in specifications and QCPs to meet compliance

• Perform online review of reports generated to ensure zero data integrity issues in Lab

• Monitor sample charging and sample pull-out as per schedule

• Monitor reserved samples storage and destruction as per schedule and perform UD release

• Monitor the stability chamber daily for excursions and other related issues

III. Drive the investigation of the batch for non-conformance and ensure its closure within the timelines defined in SOPs to facilitate smooth operations

• Evaluate root cause analysis in case of OOS, OOT, incidences and rejection and propose CAPAs

• Investigate the stability chamber excursions and propose CAPAs

• Ensure that all non-conformances are routed through proper channel and are investigated as per SOP

• Communicate with respective QC/QA heads for compliance and ensure timely closure of CAPAs by tracking in SmartSolve

IV. Monitor completion of stability studies as per protocol/schedule to avoid delays in product launch

• Perform analysis for stability samples without any errors as per schedule

• Ensure timely completion of ANDA samples testing and submission of data by verifying it with ANDA schedule

• Plan the routine/stability activities by coordinating with ADL/R&D about dates of product dossier filing

• Resolve analytical and product related issues by escalating to ADL, R&D and transfer unit

V. Provide technical guidance to the team w.r.t batch release and stability studies and evaluate their performance to ensure team development and improved lab efficiency

• Identify the training needs of employees based on the updates in the pharmacopeial guidelines

• Monitor the training imparted on laboratory techniques, quality control procedures and principles of cGMP & GLP

• Monitor the productivity of all the teams in the section by reviewing %SLA and %NC rates

• Ensure the completion of training and qualification of analyst by taking feedback and timely reviewing his work

Skills & Knowledge

• 9+ years of experience in quality control function of a pharmaceutical organisation. At least 2-3 years of experience leading a team

• Seniority level Mid-Senior level

• Employment type Full-time

• Job function Quality Assurance
• Industries Pharmaceutical Manufacturing and Retail Pharmacies

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Overview

Quality Assurance Analyst

• This is an administrative, non-technical position focused on document review and proofreading.

LegalSight is a dynamic, innovative, and growing organization. We like to have fun while taking our work very seriously. Quality control is central to LegalSight and a great quality team member is dedicated with a high degree of attention to detail!

The Quality Assurance Analyst will provide quality assessments of language translation projects in order to ensure we meet our client’s quality standards.

• This is a fully remote position.
• Working hours during the 30-day training period will be Monday - Friday 10:00 PM - 6:00 PM Brazil time. Once training is complete, working hours will change to Monday - Friday 10:00 AM - 6:00 PM Brazil time.
• Fluency in spoken and written English is required for this role as you would be collaborating with and supporting team members internationally.

• Complete quality review of translations.
• Collaborate with Project Management Team to clarify project parameters.
• Communicate effectively with vendors world-wide in order to reconcile any found errors.
• Implement process improvements using available technology solutions.

• Highly-focused, detail-oriented, and client-centric mindset
• Capable of setting and meeting deadlines
• Ability to manage time effectively
• Excellent communication skills
• Proven problem-solving skills
• Ability to work well in both independent and highly collaborative settings
• Ability to excel in fast-paced work environment
• High degree of proficiency in relevant computer skills (MS Office)

Korean Quality C ontrol R eviewer

The Language Doctors, Inc. is a US-based l i nguistic services provider known for its commitment to quality and precision. We are currently seeking a detail-oriented and bilingual Korean Quality Control Reviewer to join our team. This role is ideal for professionals fluent in Japanese and English with a strong eye for linguistic accuracy and consistency.

Key Responsibilities:

• Monitor overall document quality to ensure adherence to client-specific and internal standards throughout the review process.

• Review linguistic content to verify grammatical accuracy, appropriate terminology , and alignment with style guides and tone requirements.

• Check formatting and layout to ensure documents follow template specifications, visual consistency, and structural completeness.

• Suggest process improvements and participate in root-cause analysis when errors are detected.

• Collaborate with team members to communicate findings and escalate quality concerns as needed.

• Ensure projects are delivered within timelines while maintaining high quality.
  

Qualifications :

• Native or near-native fluency in Korean , with strong command of written and verbal English (minimum B2 CEFR level).

• Minimum 1–2 years of experience in Quality Assurance or document review, preferably in the medical or life sciences fields.

• Demonstrated attention to detail and ability to analyse complex documents for consistency and quality.

• Proficient in Microsoft Word and Excel , including formatting, comments, and revision tools.

• Strong organizational and time management skills with the ability to meet deadlines independently.

Preferred Skills:

• Experience reviewing Korean handwrit ten documents and translated texts

• Background in transcription, documentation, or translation QA

Technical Requirements :

• Computer with 8 GB RAM or higher

• Intel i5 (5th gen or newer) or equivalent processor

• Microsoft Office 2019 or later

• Reliable internet connection ( 50 Mbps minimum )

Available Schedules:

• Monday to Friday | 9 :00 AM to 5 : 30 PM EST
• Monday to Friday | 0 2 :00 PM to 10: 30 PM EST

The Language Doctors, Inc. is an equal-opportunity employer committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race,color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Visit our website at to learn more about us.

Japanese Quality C ontrol R eviewer

The Language Doctors, Inc. is a US-based l i nguistic services provider known for its commitment to quality and precision. We are currently seeking a detail-oriented and bilingual Japanese Quality Control Reviewer to join our team. This role is ideal for professionals fluent in Japanese and English with a strong eye for linguistic accuracy and consistency.

Key Responsibilities:

• Monitor overall document quality to ensure adherence to client-specific and internal standards throughout the review process.

• Review linguistic content to verify grammatical accuracy, appropriate terminology , and alignment with style guides and tone requirements.

• Check formatting and layout to ensure documents follow template specifications, visual consistency, and structural completeness.

• Suggest process improvements and participate in root-cause analysis when errors are detected.

• Collaborate with team members to communicate findings and escalate quality concerns as needed.

• Ensure projects are delivered within timelines while maintaining high quality.
  

Qualifications :

• Native or near-native fluency in Japanese , with strong command of written and verbal English (minimum B2 CEFR level).

• Minimum 1–2 years of experience in Quality Assurance or document review, preferably in the medical or life sciences fields.

• Demonstrated attention to detail and ability to analyse complex documents for consistency and quality.

• Proficient in Microsoft Word and Excel , including formatting, comments, and revision tools.

• Strong organizational and time management skills with the ability to meet deadlines independently.

Preferred Skills:

• Experience reviewing Japanese handwrit ten documents and translated texts

• Background in transcription, documentation, or translation QA

Technical Requirements :

• Computer with 8 GB RAM or higher

• Intel i5 (5th gen or newer) or equivalent processor

• Microsoft Office 2019 or later

• Reliable internet connection ( 50 Mbps minimum )

Available Schedules:

• Monday to Friday | 9 :00 AM to 5 : 30 PM EST
• Monday to Friday | 0 2 :00 PM to 10: 30 PM EST
  
• Monday to Friday| 10:00 PM to 06:30 AM EST

The Language Doctors, Inc. is an equal-opportunity employer committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race,color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Visit our website at to learn more about us.

Quality Assurance Analyst

**This is an administrative, non-technical position focused on document review and proofreading.**

LegalSight is a dynamic, innovative, and growing organization. We like to have fun while taking our work very seriously. Quality control is central to LegalSight and a great quality team member is dedicated with a high degree of attention to detail!

The Quality Assurance Analyst will provide quality assessments of language translation projects in order to ensure we meet our client’s quality standards.

Key Elements of the Role:

• This is a fully remote position.
• Working hours during the 30-day training period will be Monday - Friday 10:00PM - 6:00PM Brazil time. Once training is complete, working hours will change to Monday - Friday 10:00AM - 6:00PM Brazil time .
• Fluency in spoken and written English is required for this role as you would be collaborating with and supporting team members internationally.

Key Responsibilities:

• Complete quality review of translations.
• Collaborate with Project Management Team to clarify project parameters.
• Communicate effectively with vendors world-wide in order to reconcile any found errors.
• Implement process improvements using available technology solutions.

Essential Skills:

• Highly-focused, detail-oriented, and client-centric mindset
• Capable of setting and meeting deadlines
• Ability to manage time effectively
• Excellent communication skills
• Proven problem-solving skills
• Ability to work well in both independent and highly collaborative settings
• Ability to excel in fast-paced work environment
• High degree of proficiency in relevant computer skills (MS Office)

Quality Assurance Analyst

**This is an administrative, non-technical position focused on document review and proofreading.**

LegalSight is a dynamic, innovative, and growing organization. We like to have fun while taking our work very seriously. Quality control is central to LegalSight and a great quality team member is dedicated with a high degree of attention to detail!

The Quality Assurance Analyst will provide quality assessments of language translation projects in order to ensure we meet our client’s quality standards.

Key Elements of the Role:

• This is a fully remote position.
• Working hours during the 30-day training period will be Monday - Friday 10:00PM - 6:00PM Brazil time. Once training is complete, working hours will change to Monday - Friday 10:00AM - 6:00PM Brazil time.
• Fluency in spoken and written English is required for this role as you would be collaborating with and supporting team members internationally.

Key Responsibilities:

• Complete quality review of translations.
• Collaborate with Project Management Team to clarify project parameters.
• Communicate effectively with vendors world-wide in order to reconcile any found errors.
• Implement process improvements using available technology solutions.

Essential Skills:

• Highly-focused, detail-oriented, and client-centric mindset
• Capable of setting and meeting deadlines
• Ability to manage time effectively
• Excellent communication skills
• Proven problem-solving skills
• Ability to work well in both independent and highly collaborative settings
• Ability to excel in fast-paced work environment
• High degree of proficiency in relevant computer skills (MS Office)

Quality Assurance Analyst

**This is an administrative, non-technical position focused on document review and proofreading.**

LegalSight is a dynamic, innovative, and growing organization. We like to have fun while taking our work very seriously. Quality control is central to LegalSight and a great quality team member is dedicated with a high degree of attention to detail!

The Quality Assurance Analyst will provide quality assessments of language translation projects in order to ensure we meet our client’s quality standards.

Key Elements of the Role:

• This is a fully remote position.
• Working hours during the 30-day training period will be Monday - Friday 10:00PM - 6:00PM Brazil time. Once training is complete, working hours will change to Monday - Friday 10:00AM - 6:00PM Brazil time.
• Fluency in spoken and written English is required for this role as you would be collaborating with and supporting team members internationally.

Key Responsibilities:

• Complete quality review of translations.
• Collaborate with Project Management Team to clarify project parameters.
• Communicate effectively with vendors world-wide in order to reconcile any found errors.
• Implement process improvements using available technology solutions.

Essential Skills:

• Highly-focused, detail-oriented, and client-centric mindset
• Capable of setting and meeting deadlines
• Ability to manage time effectively
• Excellent communication skills
• Proven problem-solving skills
• Ability to work well in both independent and highly collaborative settings
• Ability to excel in fast-paced work environment
• High degree of proficiency in relevant computer skills (MS Office)

Quality Assurance Analyst

**This is an administrative, non-technical position focused on document review and proofreading.**

LegalSight is a dynamic, innovative, and growing organization. We like to have fun while taking our work very seriously. Quality control is central to LegalSight and a great quality team member is dedicated with a high degree of attention to detail!

The Quality Assurance Analyst will provide quality assessments of language translation projects in order to ensure we meet our client’s quality standards.

Key Elements of the Role:

• This is a fully remote position.
• Working hours during the 30-day training period will be Monday - Friday 10:00PM - 6:00PM Brazil time. Once training is complete, working hours will change to Monday - Friday 10:00AM - 6:00PM Brazil time.
• Fluency in spoken and written English is required for this role as you would be collaborating with and supporting team members internationally.

Key Responsibilities:

• Complete quality review of translations.
• Collaborate with Project Management Team to clarify project parameters.
• Communicate effectively with vendors world-wide in order to reconcile any found errors.
• Implement process improvements using available technology solutions.

Essential Skills:

• Highly-focused, detail-oriented, and client-centric mindset
• Capable of setting and meeting deadlines
• Ability to manage time effectively
• Excellent communication skills
• Proven problem-solving skills
• Ability to work well in both independent and highly collaborative settings
• Ability to excel in fast-paced work environment
• High degree of proficiency in relevant computer skills (MS Office)

Quality Assurance Analyst

**This is an administrative, non-technical position focused on document review and proofreading.**

LegalSight is a dynamic, innovative, and growing organization. We like to have fun while taking our work very seriously. Quality control is central to LegalSight and a great quality team member is dedicated with a high degree of attention to detail!

The Quality Assurance Analyst will provide quality assessments of language translation projects in order to ensure we meet our client’s quality standards.

Key Elements of the Role:

• This is a fully remote position.
• Working hours during the 30-day training period will be Monday - Friday 10:00PM - 6:00PM Brazil time. Once training is complete, working hours will change to Monday - Friday 10:00AM - 6:00PM Brazil time.
• Fluency in spoken and written English is required for this role as you would be collaborating with and supporting team members internationally.

Key Responsibilities:

• Complete quality review of translations.
• Collaborate with Project Management Team to clarify project parameters.
• Communicate effectively with vendors world-wide in order to reconcile any found errors.
• Implement process improvements using available technology solutions.

Essential Skills:

• Highly-focused, detail-oriented, and client-centric mindset
• Capable of setting and meeting deadlines
• Ability to manage time effectively
• Excellent communication skills
• Proven problem-solving skills
• Ability to work well in both independent and highly collaborative settings
• Ability to excel in fast-paced work environment
• High degree of proficiency in relevant computer skills (MS Office)