We have been retained by a reputed Pharmaceutical Consulting firm working in the area of GMP, Global Regulatory Affairs & Product Development to hire a "Junior GMP Consultant - QC & QA" to be based at their HO located at Navi Mumbai. Details of the position are mentioned below: Company: Our Client is a reputed Pharmaceutical Consulting firm working in the area of GMP, Global Regulatory Affairs & Product Development. They have their head office in Mumbai and subsidiaries in Europe, Singapore, Australia and Malaysia. They have been providing high quality & credible consulting services to the Pharmaceutical Industry in India and internationally. They have a young and committed team of GMP and Regulatory Experts. Role & responsibilities: Adequate experience and well versed with Quality Control and Quality Assurance systems and procedures in accordance to regulatory standards. Hands on experience in handling HPLC, GC, UV, FTIR, etc., worked on LIMS, audit trail, CSV , familiarity with GMP, GLP, EUGMP and ICH guidelines, Should have exposure working in formulations like oral solids dosage form (OSD), injectables, etc. Experience: Min 5-10 years experience in quality control & Quality Assurance in pharmaceutical industry. Knowledge & Skills Candidate should have exposure working in QC/QA laboratory in Regulated companies. Well versed with Quality Management systems/procedures Thorough knowledge of testing Raw materials, finished product, Packing materials and handling of key instrumentation like HPLC (auto sampler), GC, dissolution testing. Well versed with QC systems & procedures, audit trail review of HPLC, GC and have knowledge of computer system validation related to QC instruments. Familiarity with GMP, GLP, EUGMP and ICH guidelines. Familiar with stability management and calibration Well versed in carrying out Analytical Method validation/verification, Analytical tech transfers. Fluency in English and good communication written and verbal. Job responsibility: 1)To assist project lead in reviewing the QC systems, documentation and practices for client. 2) Participate in Supplier audits at various sites 3) Maintaining GMP data base and preparation of SOPs 4) Ready to do extensive travelling to visit Client sites and supplier audits (domestic & international) Preferred candidate: Candidates based only in Mumbai/Navi Mumbai will be preferred. 6. Qualifications: Education: A masters degree in Pharmaceutical Sciences or a master's degree in Analytical Chemistry Skills and Competencies: Strong analytical and problem-solving skills. Attention to detail and accuracy in testing and documentation. Proficient in the use of laboratory equipment and software. Those of you whose profile matches the above mentioned description and would like to apply for this position shall forward their updated CV to sudhirvinayak@gmail.com In case of a query, please feel free to speak to the undersigned: Sudhir Vinayak, Director, Pharma Placements Inc. Mobile: 98202 34987 / 81307 24980
