Quality Assurance Job at PolyPeptide | Pharmacy Graduates Apply Now for the Officer Role
PolyPeptide Group, a specialized CDMO for peptide-based APIs, is seeking a proactive Officer – Quality Assurance for its API manufacturing site in Ambernath, India. This Quality Assurance Job requires 3–6 years of experience in QA within API pharma manufacturing. The Officer will be instrumental in maintaining the Quality Management System, conducting meticulous batch record reviews, leading investigations of OOS/deviations, and managing change controls. This position demands expert knowledge of cGMP/cGLP/GDP and audit management to ensure API release compliance.
- Job Title: Officer – Quality Assurance
- Location: Ambernath, India
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.
Pharmacy Job 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 of the Pharmacy Job
- 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
- 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
