Job Description

Job Summary:

We are seeking a motivated and knowledgeable Quality Assurance (QA) professional to manage compliance activities related to third-party pharmaceutical manufacturing and packaging sites. The ideal candidate will ensure that all contract manufacturing organizations (CMOs) operate in alignment with current regulatory guidelines (cGMP, ICH, WHO, etc.) and internal quality systems, from production to release.

Key Responsibilities:

Coordinate with third-party manufacturing (TPM) and packaging sites to ensure adherence to company and regulatory quality standards. Review and approve batch manufacturing records (BMRs) and batch packaging records (BPRs) from TPMs. Monitor and support investigation of deviations, change controls, and CAPAs for timely resolution. Conduct periodic quality audits and site visits; prepare audit reports and follow up on observations. Review and approve quality documentation (SOPs, protocols, reports) submitted by TPMs. Ensure timely QA product release by coordinating with site QA teams and internal departments. Maintain and update Quality Agreements with third-party manufacturing partners. Support customer audits and regulatory inspections (WHO, MHRA, USFDA, etc.) at TPM sites. Track and report key quality metrics to management related to third-party operations. Provide training and support to QA/QC teams at third-party sites when required. Collaborate with internal teams including Regulatory Affairs, Production, R&D, and Supply Chain for smooth operations. Manage new product registration processes and associated documentation. Oversee brand registration on Trade Safe platform. Handle NPPA/DPCO-related compliance and submissions. Coordinate with labs for sample testing activities and ensure timely Certificate of Analysis (COA) issuance.

Qualifications:

B.Pharm / M.Pharm / M.Sc. in Life Sciences. 2-5 years of QA experience in the pharmaceutical industry, preferably in a corporate QA or third-party manufacturing role. Sound knowledge of cGMP, ICH guidelines, and Indian regulatory frameworks. Hands-on experience in batch record review, documentation control, and vendor compliance. Familiarity with NPPA/DPCO requirements and regulatory processes.

Desired Skills:

Experience working with multiple third-party manufacturers and packagers. Strong communication and coordination skills across cross-functional and external teams. Proficiency in MS Office and quality documentation tools. Willingness to travel to TPM sites for audits, training, or compliance support.
Job Types: Full-time, Permanent

Pay: Up to ?40,000.00 per month

Benefits:

Health insurance Provident Fund
Work Location: In person