Executive – Global Quality Assurance

Job Title: Executive – Global Quality Assurance

Location: Ambernath, India

Job Type: Full-Time

Reporting: Global QA Senior Specialist

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:

The Global QA – Documentation Specialist plays a critical role in supporting the organization’s quality assurance framework, with a primary focus on managing and maintaining global quality documentation. This role ensures the effective implementation and maintenance of the electronic Quality Management System (eQMS), promoting compliance, consistency, and accessibility of quality documents across the organization.

Key Responsibilities:

• Initiate and manage workflows for global quality documents, including changes and deviations, within the eQMS, including follow-up and ensure timely completion on actions.
• Maintain and update global quality document templates and standardized forms up to date.
• Develop, revise, and manage global training modules within the eQMS.
• Monitor and track periodic reviews of global quality documents to ensure ongoing compliance.
• Communicate document status updates and changes to relevant stakeholders.
• Support global quality initiatives, including:
  • Quality agreements
  • Supplier and material qualification
  • Periodic requalification
  • Documentation and follow-up activities in the eQMS
• Make changes in the eQMS according to plan.
• Make corrections and changes in ERP Master Data according to plan.

Qualifications & Requirements:

• Bachelor’s or Master’s degree in Chemistry (B.Sc. / M.Sc.) or a related scientific discipline.
• Minimum of 5 years of experience in the pharmaceutical or medical device industry.
• At least 3 years of experience in a quality assurance role.
• Hands-on experience with electronic Quality Management Systems (eQMS).
• Strong understanding of Good Manufacturing Practices (GMP) and regulatory compliance standards.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Excellent written and verbal communication skills in English.

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 our Global Quality Assurance 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.