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.
