Quality Assurance Manager

Company overview

QIMA’s food division supports the global food chain by helping businesses protect food safety, verify product quality, and maintain responsible working conditions and sustainable practices. Through inspections, audits, and certifications, the team works with growers, manufacturers, retailers, food service businesses, and hospitality operators to keep products safe from source to shelf and table.

QIMA operates in more than 100 countries and works with over 30,000 brands, retailers, manufacturers, and growers across consumer products, food, and life sciences. EFRAC, part of the QIMA group, provides laboratory testing services focused on food safety, pharmaceutical quality control, and environmental monitoring.

The company emphasizes a values-driven culture built around client focus, integrity, and simplicity.

Role summary

The organization is seeking an experienced Quality Assurance Manager for its pharmaceutical analytical testing laboratory. This position will own the quality assurance function, strengthen the quality management system, and ensure the lab remains compliant with regulatory expectations and industry standards. The role involves deep involvement in audits, documentation control, CAPA management, risk mitigation, and team capability building.

Core responsibilities

You will be responsible for maintaining and improving the lab’s quality framework, coordinating regulatory and internal audits, and ensuring all quality-related processes operate effectively and consistently.

Quality system and documentation

Build, update, and sustain the quality management system so it aligns with regulatory frameworks such as USFDA, WHO, NABL, and GLP, as well as standards like ISO and ICH. Manage key quality documents including SOPs, batch records, test methods, and analytical reports, while also introducing risk controls to reduce quality-related issues.

Audits and compliance

Take the lead on USFDA, WHO, NABL, GLP, and other regulatory inspections. Plan and run internal audits, evaluate the effectiveness of the lab’s quality processes, and ensure findings are addressed promptly through well-executed corrective and preventive actions. Act as the main contact during external audits, inspections, and accreditation assessments, and work with regulators and other stakeholders to support ongoing compliance and improvement.

CAPA ownership

Drive the full corrective and preventive action process, including investigation of deviations and non-conformances, root cause analysis, documentation, and implementation of sustainable fixes. Track whether actions remain effective and make sure solutions are embedded into routine lab operations.

Leadership and training

Guide, coach, and train laboratory staff on quality expectations, testing procedures, compliance requirements, and internal processes. Run recurring training programs to maintain GMP, GLP, and audit readiness, and encourage a culture focused on continuous improvement and proactive issue resolution.

Reporting and records

Ensure quality reports, analytical results, audit summaries, CAPA records, and other compliance documents are accurate, complete, and submitted on time. Maintain records in a manner that supports regulatory requirements, internal control, and audit preparedness, and prepare quality metrics for senior leadership and regulatory needs.

Testing review and issue resolution

Oversee the review and approval of analytical results to confirm they meet specifications, applicable regulations, and SOP requirements. Investigate out-of-specification results and other discrepancies, then lead the root-cause analysis and corrective action process until closure.

Continuous improvement

Spot opportunities to strengthen reliability, efficiency, and compliance across quality processes. Stay current on evolving regulations, industry practices, and technical expectations so the lab continues to operate to high standards.

Qualifications

A bachelor’s or master’s degree in Chemistry, Biology, Pharmaceutical Sciences, or a related discipline is required. Additional certifications in quality management, such as Six Sigma or ISO 9001, or exposure to regulatory affairs will be considered an advantage.

Candidates should bring at least 15 years of experience in quality management within a pharmaceutical testing laboratory and have a strong track record of handling USFDA, WHO, NABL, GLP, CAPA, and internal audits. A strong understanding of GMP, GLP, FDA, EMA, and ICH requirements is essential, along with hands-on experience in CAPA investigations, root cause analysis, and implementing preventive measures.

Skills and profile

The ideal professional will be a strong leader with excellent communication and interpersonal skills, high attention to detail, and the ability to solve problems and manage risk effectively. Familiarity with laboratory instruments, analytical methods, and pharmaceutical testing practices is important, as is confidence in audit preparation, document review, and regulatory reporting.

Application instructions

Interested candidates can share an updated resume by email. When applying, mention Application for QA Manager – Pharma Testing Laboratory in the subject line.

Additional details to include with the resume

• Total experience
• Current CTC
• Expected CTC
• Notice period
• Current location
• Whether relocation to Kolkata is comfortable

Contact information

Email: [email protected], [email protected]

Phone: +91 62922 79952