Officer – Quality Assurance

Job Title: Officer – Quality Assurance

Location: Ambernath, India

Job Type: Full Time

Reporting: Sr. Manager - 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 are seeking a detail-oriented and proactive Officer – QA to ensure compliance with cGMP, cGLP, and GDP practices at our API manufacturing site. The ideal candidate will play a key role in implementing and maintaining the Quality Management System, overseeing batch record reviews, managing audits, and ensuring adherence to regulatory standards. This position requires strong technical knowledge, problem-solving skills, and the ability to collaborate across departments to maintain product quality and compliance.

Key Responsibilities:

• Implement and maintain Quality Management System and cGMP/cGLP/GDP practices at the site
• Review batch production records and laboratory control records prior to API release
• Oversee investigations and closure of critical deviations, OOS, and change controls
• Review procedures, reprocess/rework activities, and quality-impacting documents
• Lead internal, customer, and regulatory audits; prepare audit and quality reports
• Ensure calibration, equipment maintenance, and stability studies are effectively managed
• Conduct supplier audits and manage dispatch activities.
• Manage document control through QUMAS and system-related QA activities in AX
• Manage qualification and validation activities for equipment and processes

Required Skills & Qualifications:

Education: Bachelor’s or master’s degree in pharmacy, Chemistry, or related discipline

Experience: 3–6 years of experience in Quality Assurance within API pharmaceutical manufacturing

Key Skills & Competencies:

• In-depth knowledge of cGMP/cGLP/GDP practices and regulatory compliance and audit processes
• Experience in batch record review, OOS investigations, and change control management
• Proficiency in QMS tools, QUMAS, and ERP systems (AX preferred)
• Strong documentation and organizational skills
• Excellent communication and cross-functional collaboration abilities
• Ability to lead audits and manage customer interactions effectively

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.