5 jobs in EFRAC Lab

Quality Assurance MANAGER ( PHARMA)

We are looking for a highly skilled Quality Assurance Manager to lead and manage the Quality Assurance function in our Analytical Testing Laboratory . The ideal candidate will have extensive experience in handling critical audits, including USFDA , CAPA , GLP , WHO , NABL , and internal audits , and will play a key role in ensuring compliance with pharmaceutical regulatory requirements and industry best practices. This role demands expertise in maintaining robust quality systems, managing audits, and driving corrective and preventive actions (CAPA) to ensure the lab operates to the highest quality standards.

Key Responsibilities :

Quality System Management :

• Develop, implement, and maintain the Quality Management System (QMS) to comply with regulatory requirements (USFDA, WHO, NABL, GLP) and industry standards (ISO, ICH).
• Oversee the preparation and management of documentation including standard operating procedures (SOPs), batch records, test methods, and analytical reports to ensure compliance with regulatory standards.
• Implement risk management strategies to identify, assess, and mitigate quality-related risks within the testing laboratory.

Audit and Compliance Oversight :

• Lead and manage USFDA , WHO , NABL , GLP , and other regulatory audits, ensuring full preparedness and compliance.
• Coordinate and conduct internal audits to assess the effectiveness of the laboratory‘s quality system, identifying areas for improvement and ensuring alignment with company policies and regulatory standards.
• Ensure timely and effective resolution of audit findings by developing and executing Corrective and Preventive Actions (CAPA) in accordance with regulatory guidelines and company practices.
• Serve as the primary point of contact during external regulatory audits, inspections, and accreditation assessments.
• Collaborate with regulatory bodies and external stakeholders to ensure continuous improvement in quality and compliance.

CAPA Management :

• Lead the CAPA (Corrective and Preventive Action) process, ensuring thorough investigation and documentation of non-conformances, root cause analysis, and implementation of effective corrective and preventive actions.
• Track CAPA effectiveness and ensure corrective actions are sustainably integrated into the laboratory processes to prevent recurrence of issues.

Team Leadership & Training :

• Supervise, mentor, and train laboratory personnel on quality standards, testing protocols, regulatory compliance, and internal procedures.
• Conduct regular training sessions to ensure team competency in GMP, GLP, and audit readiness.
• Promote a culture of continuous quality improvement across the lab, encouraging proactive problem-solving and adherence to quality systems.

Regulatory Reporting & Documentation :

• Ensure accurate and timely reporting of analytical results, audit outcomes, CAPA documentation, and other quality metrics.
• Ensure all records are properly maintained to meet regulatory requirements, internal standards, and audit readiness.
• Prepare quality reports and metrics for senior management and regulatory submissions.

Testing Oversight & Review :

• Oversee the review and approval of analytical test results, ensuring compliance with specifications, regulatory guidelines, and SOPs.
• Investigate any discrepancies or out-of-specification (OOS) results and drive the resolution through root cause analysis and corrective actions.

Continuous Improvement & Risk Management :

• Identify and implement improvements to quality management processes, ensuring efficiency, compliance, and reliability of testing systems.
• Monitor emerging industry trends, regulations, and best practices, ensuring the laboratory’s practices remain at the forefront of industry standards.

Qualifications :

• Education : Bachelor‘s or Master’s degree in Chemistry, Biology, Pharmaceutical Sciences, or a related field. Certifications in Quality Management (e.g., Six Sigma, ISO 9001, or equivalent) or regulatory affairs are a plus.

Experience :

• Minimum of 15 years of experience in a Quality Management role within a pharmaceutical testing laboratory.
• Proven experience in managing and handling audits such as USFDA , WHO , NABL , GLP , CAPA , and internal audits .
• In-depth knowledge of regulatory standards and guidelines including GMP , GLP , FDA , EMA , and ICH .
• Experience leading CAPA investigations, root cause analysis, and implementing corrective/preventive measures.

Skills :

• Strong leadership skills with the ability to mentor and lead teams to achieve compliance and quality objectives.
• Excellent communication and interpersonal skills to interact effectively with regulatory authorities, senior management, and cross-functional teams.
• Detail-oriented with strong problem-solving skills and the ability to assess and mitigate risks effectively.
• Familiarity with laboratory instrumentation, analytical techniques, and pharmaceutical testing standards.
• Proficient in audit preparation, documentation review, and regulatory reporting.

How to Apply

Interested candidates may contact us or share their updated resume at the following email addresses:

/

Contact:

While applying, please mention “Application for QA Manager – Pharma Testing Laboratory” in the subject line.

Kindly include the following details along with your resume:

• Total Experience:
• Current CTC:
• Expected CTC:
• Notice Period:
• Current Location :
• Are you comfortable for relocation to Kolkata?

Quality Assurance MANAGER-Pharma or Food /TIC Industry

We are looking for a highly skilled Quality Assurance Manager to lead and manage the Quality Assurance function in our Analytical Testing Laboratory . The ideal candidate will have extensive experience in handling critical audits, including USFDA , CAPA , GLP , WHO , NABL , and internal audits , and will play a key role in ensuring compliance with pharmaceutical regulatory requirements and industry best practices. This role demands expertise in maintaining robust quality systems, managing audits, and driving corrective and preventive actions (CAPA) to ensure the lab operates to the highest quality standards.

Key Responsibilities :

Quality System Management :

• Develop, implement, and maintain the Quality Management System (QMS) to comply with regulatory requirements (USFDA, WHO, NABL, GLP) and industry standards (ISO, ICH).
• Oversee the preparation and management of documentation including standard operating procedures (SOPs), batch records, test methods, and analytical reports to ensure compliance with regulatory standards.
• Implement risk management strategies to identify, assess, and mitigate quality-related risks within the testing laboratory.

Audit and Compliance Oversight :

• Lead and manage USFDA , WHO , NABL , GLP , and other regulatory audits, ensuring full preparedness and compliance.
• Coordinate and conduct internal audits to assess the effectiveness of the laboratory's quality system, identifying areas for improvement and ensuring alignment with company policies and regulatory standards.
• Ensure timely and effective resolution of audit findings by developing and executing Corrective and Preventive Actions (CAPA) in accordance with regulatory guidelines and company practices.
• Serve as the primary point of contact during external regulatory audits, inspections, and accreditation assessments.
• Collaborate with regulatory bodies and external stakeholders to ensure continuous improvement in quality and compliance.

CAPA Management :

• Lead the CAPA (Corrective and Preventive Action) process, ensuring thorough investigation and documentation of non-conformances, root cause analysis, and implementation of effective corrective and preventive actions.
• Track CAPA effectiveness and ensure corrective actions are sustainably integrated into the laboratory processes to prevent recurrence of issues.

Team Leadership & Training :

• Supervise, mentor, and train laboratory personnel on quality standards, testing protocols, regulatory compliance, and internal procedures.
• Conduct regular training sessions to ensure team competency in GMP, GLP, and audit readiness.
• Promote a culture of continuous quality improvement across the lab, encouraging proactive problem-solving and adherence to quality systems.

Regulatory Reporting & Documentation :

• Ensure accurate and timely reporting of analytical results, audit outcomes, CAPA documentation, and other quality metrics.
• Ensure all records are properly maintained to meet regulatory requirements, internal standards, and audit readiness.
• Prepare quality reports and metrics for senior management and regulatory submissions.

Testing Oversight & Review :

• Oversee the review and approval of analytical test results, ensuring compliance with specifications, regulatory guidelines, and SOPs.
• Investigate any discrepancies or out-of-specification (OOS) results and drive the resolution through root cause analysis and corrective actions.

Continuous Improvement & Risk Management :

• Identify and implement improvements to quality management processes, ensuring efficiency, compliance, and reliability of testing systems.
• Monitor emerging industry trends, regulations, and best practices, ensuring the laboratory’s practices remain at the forefront of industry standards.

Qualifications :

• Education : Bachelor's or Master’s degree in Chemistry, Biology, Pharmaceutical Sciences, or a related field. Certifications in Quality Management (e.g., Six Sigma, ISO 9001, or equivalent) or regulatory affairs are a plus.

Experience :

• Minimum of 12+ years of experience in a Quality Management role within a pharmaceutical testing laboratory.
• Proven experience in managing and handling audits such as USFDA , WHO , NABL , GLP , CAPA , and internal audits .
• In-depth knowledge of regulatory standards and guidelines including GMP , GLP , FDA , EMA , and ICH .
• Experience leading CAPA investigations, root cause analysis, and implementing corrective/preventive measures.

Skills :

• Strong leadership skills with the ability to mentor and lead teams to achieve compliance and quality objectives.
• Excellent communication and interpersonal skills to interact effectively with regulatory authorities, senior management, and cross-functional teams.
• Detail-oriented with strong problem-solving skills and the ability to assess and mitigate risks effectively.
• Familiarity with laboratory instrumentation, analytical techniques, and pharmaceutical testing standards.
• Proficient in audit preparation, documentation review, and regulatory reporting.

How to Apply

Interested candidates may contact us or share their updated resume at the following email addresses:

Contact: +

While applying, please mention “Application for QA Manager-Kolkata” in the subject line.

Kindly include the following details along with your resume:

• Total Experience:
• Relevant Experience in QA:
• Current CTC:
• Expected CTC:
• Notice Period:
• Current Location:
• Are you comfortable for relocation to Kolkata?

Quality Assurance MANAGER ( PHARMA)

We are looking for a highly skilled Quality Assurance Manager to lead and manage the Quality Assurance function in our Analytical Testing Laboratory . The ideal candidate will have extensive experience in handling critical audits, including USFDA , CAPA , GLP , WHO , NABL , and internal audits , and will play a key role in ensuring compliance with pharmaceutical regulatory requirements and industry best practices. This role demands expertise in maintaining robust quality systems, managing audits, and driving corrective and preventive actions (CAPA) to ensure the lab operates to the highest quality standards.

Key Responsibilities :

Quality System Management :

• Develop, implement, and maintain the Quality Management System (QMS) to comply with regulatory requirements (USFDA, WHO, NABL, GLP) and industry standards (ISO, ICH).
• Oversee the preparation and management of documentation including standard operating procedures (SOPs), batch records, test methods, and analytical reports to ensure compliance with regulatory standards.
• Implement risk management strategies to identify, assess, and mitigate quality-related risks within the testing laboratory.

Audit and Compliance Oversight :

• Lead and manage USFDA , WHO , NABL , GLP , and other regulatory audits, ensuring full preparedness and compliance.
• Coordinate and conduct internal audits to assess the effectiveness of the laboratory's quality system, identifying areas for improvement and ensuring alignment with company policies and regulatory standards.
• Ensure timely and effective resolution of audit findings by developing and executing Corrective and Preventive Actions (CAPA) in accordance with regulatory guidelines and company practices.
• Serve as the primary point of contact during external regulatory audits, inspections, and accreditation assessments.
• Collaborate with regulatory bodies and external stakeholders to ensure continuous improvement in quality and compliance.

CAPA Management :

• Lead the CAPA (Corrective and Preventive Action) process, ensuring thorough investigation and documentation of non-conformances, root cause analysis, and implementation of effective corrective and preventive actions.
• Track CAPA effectiveness and ensure corrective actions are sustainably integrated into the laboratory processes to prevent recurrence of issues.

Team Leadership & Training :

• Supervise, mentor, and train laboratory personnel on quality standards, testing protocols, regulatory compliance, and internal procedures.
• Conduct regular training sessions to ensure team competency in GMP, GLP, and audit readiness.
• Promote a culture of continuous quality improvement across the lab, encouraging proactive problem-solving and adherence to quality systems.

Regulatory Reporting & Documentation :

• Ensure accurate and timely reporting of analytical results, audit outcomes, CAPA documentation, and other quality metrics.
• Ensure all records are properly maintained to meet regulatory requirements, internal standards, and audit readiness.
• Prepare quality reports and metrics for senior management and regulatory submissions.

Testing Oversight & Review :

• Oversee the review and approval of analytical test results, ensuring compliance with specifications, regulatory guidelines, and SOPs.
• Investigate any discrepancies or out-of-specification (OOS) results and drive the resolution through root cause analysis and corrective actions.

Continuous Improvement & Risk Management :

• Identify and implement improvements to quality management processes, ensuring efficiency, compliance, and reliability of testing systems.
• Monitor emerging industry trends, regulations, and best practices, ensuring the laboratory’s practices remain at the forefront of industry standards.

Qualifications :

• Education : Bachelor's or Master’s degree in Chemistry, Biology, Pharmaceutical Sciences, or a related field. Certifications in Quality Management (e.g., Six Sigma, ISO 9001, or equivalent) or regulatory affairs are a plus.

Experience :

• Minimum of 15 years of experience in a Quality Management role within a pharmaceutical testing laboratory.
• Proven experience in managing and handling audits such as USFDA , WHO , NABL , GLP , CAPA , and internal audits .
• In-depth knowledge of regulatory standards and guidelines including GMP , GLP , FDA , EMA , and ICH .
• Experience leading CAPA investigations, root cause analysis, and implementing corrective/preventive measures.

Skills :

• Strong leadership skills with the ability to mentor and lead teams to achieve compliance and quality objectives.
• Excellent communication and interpersonal skills to interact effectively with regulatory authorities, senior management, and cross-functional teams.
• Detail-oriented with strong problem-solving skills and the ability to assess and mitigate risks effectively.
• Familiarity with laboratory instrumentation, analytical techniques, and pharmaceutical testing standards.
• Proficient in audit preparation, documentation review, and regulatory reporting.

How to Apply

Interested candidates may contact us or share their updated resume at the following email addresses:

/

Contact:

While applying, please mention “Application for QA Manager – Pharma Testing Laboratory” in the subject line.

Kindly include the following details along with your resume:

• Total Experience:
• Current CTC:
• Expected CTC:
• Notice Period:
• Current Location :
• Are you comfortable for relocation to Kolkata?

Location: Preferred Kolkata but flexible

Full-time | Back Office | Entry to Mid-Level

ABOUT EFRAC

EFRAC, part of the QIMA Group, is a leading quality control, testing, and compliance service provider delivering comprehensive solutions across Food, Pharma, Packaging, Environment, and Gas sectors. As part of QIMA's global network operating in 85+ countries, our Certification division issues Global GAP certificates and manages SMETA audit cycles for hundreds of producers and suppliers worldwide.

ABOUT THE ROLE

As a Back-Office Executive, you will work across both Global GAP and SMETA certification programs - handling scheduling, data entry, client follow-up, corrective action tracking, and file management. No prior certification experience is required: we train you on Global GAP and SMETA operations. What matters is that you are organized, precise, and able to handle high volumes without losing accuracy.

Note for agencies: We are hiring multiple executives for this role. Candidates with TIC, audit coordination, or compliance administration backgrounds are ideal but not mandatory.

AUDIT SCHEDULING AND COORDINATION

- Schedule audits with clients (farms, producers, factories, suppliers) across time zones

- Confirm audit assignments with auditors and field teams

- Send pre-audit documentation packages and confirm client readiness

- Monitor upcoming audit dates and flag delays to the Documentation Manager

REPORT AND CERTIFICATE OPERATIONS

- Receive completed audit reports, run initial completeness checks, and route to Technical Review

- Data-enter audit outcomes into internal trackers and scheme portals as directed

- Support certificate preparation, dispatch, and client delivery

- Maintain digital filing systems for reports, certificates, and supporting evidence

CORRECTIVE ACTION AND FOLLOW-UP

- Track open corrective actions (NCs / CAPRs) and send reminders to clients at defined intervals

- Receive and log corrective action evidence submitted by clients

- Coordinate with Technical Reviewers on CAPA closure verification

- Update trackers and notify clients of closure or escalation decisions

CLIENT AND INTERNAL COMMUNICATION

- Handle routine client queries on audit status, certificate validity, and portal registration

- Escalate complex or technical queries to the Documentation Manager or Technical Reviewer

- Support internal teams with data pulls, report generation, and ad hoc administrative tasks

REQUIREMENTS - MUST HAVE

- 1-3 years of experience in back-office operations, coordination, compliance administration, or a similar role

- Strong proficiency in Excel or Google Sheets

- Ability to manage multiple tasks simultaneously with strict attention to accuracy and deadlines

- Good written English for professional client and team communication

- Comfortable working in a high-volume, process-driven environment

REQUIREMENTS - PREFERRED

- Prior experience at a certification body, inspection company, or audit firm

- Familiarity with Sedex, Global GAP portal, or any audit management software

- Experience in agricultural, food safety, or ethical trade sectors

- Second language: Spanish, French, Arabic, Chinese, or Portuguese

- Experience with SharePoint, Salesforce, or similar platforms