Global QA Specialist

Job Title : Global QA Specialist

Location : Ambernath, India

Job Type : Full Time

Reporting : Global QA Senior Specialist, Global Quality Assurance

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.

Position Overview :

We're looking for a passionate and experienced professional to join our Global QA team. You'll support the organization with activities related to supplier and material qualification, manage global quality documents, and oversee changes and deviations - ensuring compliance and driving continuous improvement across operations.

Key Responsibilities :

• Lead regular team meetings to track progress on supplier qualification activities
• Prepare and maintain global annual audit and re-qualification plans
• Coordinate vendor audit activities in alignment with global standards
• Support execution of supplier audits and qualification processes
• Develop and update global quality procedures, forms, and templates
• Manage global quality documentation, including changes and deviations

Must-Have Qualifications :

We believe that you are ready for new and exciting challenges in a global QA role. You have several years of experience with quality work within the pharma or medical device industry. You have high GMP understanding as well as knowledge of regulatory requirements and guidelines.

You enjoy supporting and coaching co-workers but are also able to challenge procedures and introduce alternative options.

Your profile :

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.

Skills Required

Regulatory compliance standards