Global Qa Specialist

4 weeks ago

Amarnath MH IN PolyPeptide Group Full time

Job Title Global QA Specialist Location Ambernath India Job Type Full Time Reporting Global QA Senior Specialist Global 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 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 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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