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.

Assistant Manager - Quality Assurance