Officer - Quality Assurance

2 weeks ago

Amarnath, India PolyPeptide Group Full time

**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**:
**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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