Assistant Manager - Quality AssuranceQuality Assurance & Regulatory Affairs·Ambernath

Department: Quality Assurance

Location: Ambernath

Reports To: Head – Quality Assurance

Experience: 12–15 years of experience in Quality Assurance within API pharmaceutical manufacturing

Education: Master’s degree in Chemistry, or related discipline

About PolyPeptide Group: PolyPeptide Group AG and its consolidated subsidiaries (“PolyPeptide”) is a specialized Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide serves a fast-growing market, offering products and services from pre clinical to commercial stages. Its broad portfolio reflects the opportunities in drug therapies across areas and with a large exposure to metabolic diseases, including GLP-1. Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India. PolyPeptide’s shares (SIX: PPGN) are listed on SIX Swiss Exchange.

Key Responsibilities:

• Implement and maintain the Quality Management System (QMS) in compliance with cGMP/cGLP/GDP requirements

• Manage licensing activities including preparation, review, and submission of regulatory documents and coordination with regulatory authorities

• Ensure effective control and management of QMS documentation including SOPs, specifications, STPs, protocols, and reports

• Review and approve batch manufacturing records (BMR) and batch packing records (BPR) prior to API release

• Prepare, review, and monitor Annual Product Quality Review (APQR) reports as per regulatory requirements

• Generate and review trend reports for deviations, OOS, OOT, complaints, and CAPA effectiveness

• Handle deviations, OOS, OOT, change controls, and ensure timely investigation, root cause analysis, and closure

• Lead and support internal, external, customer, and regulatory audits; ensure timely closure of audit observations

• Prepare quality reports, dashboards, and metrics for management review

• Oversee qualification and validation activities including equipment qualification (IQ/OQ/PQ), process validation, and cleaning validation

• Ensure proper implementation of stability studies and data review

• Support vendor qualification and supplier audits

• Ensure training compliance and conduct cGMP training programs

• Maintain data integrity and ensure adherence to ALCOA+ principles

• Coordinate with cross-functional teams for compliance and continuous improvement initiatives

Required Skills & Qualifications:

Key Skills & Competencies:

• Strong knowledge of regulatory requirements (USFDA, EU GMP, WHO, ICH guidelines)

• Hands-on experience in licensing management and regulatory documentation

• Expertise in QMS processes including deviations, CAPA, change control, and documentation control

• Experience in APQR preparation and quality trend analysis

• Good understanding of qualification and validation concepts

• Strong audit handling skills (internal, external, regulatory)

• Proficiency in QMS software (e.g., QUMAS) and ERP systems

• Excellent analytical, documentation, and problem-solving skills

• Effective communication and stakeholder management abilities

• Ability to work in a cross-functional and fast-paced environment

· Why Join Us at PolyPeptide Group: PolyPeptide Group offers an exciting opportunity to work at the forefront of peptide-based therapeutics, a rapidly growing and innovative segment of the pharmaceutical industry. As a key member of PolyPeptide team, you will have the opportunity to contribute to a company that is dedicated to the success of its clients and the advancement of peptide science. Join us and be part of a global organization that is shaping the future of life-saving therapies.

Department

Quality Assurance & Regulatory Affairs

Locations

Ambernath

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