Officer – Quality Assurance

2 weeks ago

Ulhasnagar, Maharashtra, India PolyPeptide Group Full time ₹ 4,00,000 - ₹ 8,00,000 per year

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.

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