About the role

Job Title: Global QA Specialist Location: Ambernath, India

Job Type: Full Time

Reporting: Global QA Senior Specialist, Global Quality Assurance

5 Days Week

Global MNC || CDMO

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’re looking for a passionate and experienced professional to join our Global QA team.

As a global QA specialist working with global computerized systems, you will have an operational focus when being involved in many parts of our business and need to navigate in an environment that has a high tempo and is changeable to able to meet the high demands.

Key Responsibilities:

• Actively support digitalization projects.

• Actively support validation of GMP related computerized systems • Support preparation of life cycle documentation for GMP related computerized systems, e.g., validation documents, periodic reviews, change requests, deviations, risk assessments, procedures

• Support in audits by authorities and customers of PolyPeptide • Support in qualification of software vendors Must-Have

Qualifications: We believe that you are ready for new and exciting challenges in a global QA role. You have several years of experience with QA work and validation of computerized systems within the pharma or medical device industry.

You have high GMP understanding as well as knowledge of regulatory requirements, and guidelines related to computerized systems and GMP compliance (e.g., 21 CFR Part 11, Data integrity, GAMP 5).

You enjoy supporting and coach co-workers but are also able to challenge procedures and introduce alternative options. You need to have:

• Minimum 5 years’ experience within Pharma or Medical Device industry • Minimum 3 years’ experience within a quality function

• Excellent communications skills in English

• Bachelor/Master/PhD degree in scientific life sciences, or equal

• Auditor qualification is a merit Describe in the application:

• Which QMS, ERP, LIMS systems you have worked in and in which roles.

• Which types of documents you have worked with, for which type of systems (QMS, ERP, LIMS, equipment/instrument software) and in which roles (author, reviewer, approver).