2 Eu Gmp Jobs

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

Role & responsibilities : CORPORATE QUAKLITY ASSURANCE 1. Specification Preparation & Documentation Develop and maintain specifications for raw materials (APIs, excipients) and packing materials. Ensure specifications comply with pharmacopeial standards and in-house quality standards. Review and update specifications based on regulatory updates, stability studies, and supplier changes. Coordinate with purchase, packaging development, QC, and regulatory teams for finalizing specifications. 2. Raw Material (RM) Specification Management Maintain records of Material Safety Data Sheets (MSDS) and Certificates of Analysis (COA) from suppliers. 3. Packing Material (PM) Specification Management Develop specifications for primary, secondary, and tertiary packaging materials. Ensure packing materials comply with stability, compatibility, and regulatory requirements. Conduct compatibility studies to assess interaction with drug formulations. Define parameters like GSM, burst strength, WVTR, dimensions, artwork compliance. 4. Regulatory & Compliance Assurance Ensure regulatory compliance with global standards (USFDA, WHO-GMP) Assist in audit preparation and responses related to material specifications. Ensure proper documentation and version control of Master Specification Files. 5. Vendor & Cross-functional Coordination Collaborate with vendors for RM & PM specification approvals. Work with Quality Control (QC), Quality Assurance, and Procurement to resolve material specification issues. Participate in vendor qualification, site audits, and material evaluation. 6. Acting as SPOC Between Factory & Corporate Serve as the primary liaison between the corporate QA team and the factory team regarding RM & PM specifications. Ensure smooth communication and implementation of corporate quality standards at the factory level. Address and resolve factory concerns related to RM & PM specifications in coordination with corporate QA. 7.Addressing Factory Concerns & Quality Compliance Resolve factory-level issues related to raw and packing materials by aligning corporate directives. Support factory teams in implementing quality control procedures for RM & PM. Ensure material handling, storage, and testing compliance at factory sites. Coordinate and support regulatory inspections and customer audits at manufacturing sites. Ensure timely CAPA (Corrective and Preventive Action) implementation post-audits. Maintain audit readiness across manufacturing and distribution facilities Design and approve the corporate documents to meet highest levels of quality standards. Conduct vendor audits and qualification for raw materials, packing materials, and contract manufacturers (P2P). Collaborate with the Procurement Department to ensure suppliers meet the required quality standards. Establish quality agreements with vendors and monitor compliance. specifications in coordination with corporate QA. Knowledge Required 1. 8 10years of relevant experience in Pharma industry. 2. Strong knowledge of pharmacopeia standards (IP, USP, BP, EP). 3. Expertise in specification writing and document management. 4. Knowledge of analytical techniques (HPLC, GC, UV, Titration, etc.). 5. Familiarity with ICH Q3C, Q6A, GMP, and GDP guidelines. 6. Knowledge of Specification Preparation of Raw Material / Packing Material / Finished Product 7. Knowledge of Pharmacopeia Monograph - Indian Pharmacopoeia / British Pharmacopoeia / United States Pharmacopoeia 8. Must have knowledge of General Testing Procedures related to Raw Material / Packing Material / Finished Product testing. 9. Must have proficiency in computer operating ( Specially MS Word ) 10. Able to communicate effectively with Factory Site and Purchase / RA Dept.. 11. Shall be able to communicate with Purchase Dept. related to P2P products. 12. Ensure cross-functional teams (Production, Purchase, Regulatory Affairs) are aligned with quality expectations. 13. Should be able to travel to third party site/s. 14. Should possess good verbal and written communication skills. 15. Exposure to regulatory agencies audits such as Schedule - M, USFDA, MHRA, WHO, ISO etc. Please note: Female candidate is preferred provided she should be able to travel outstation once in week on monthly basis.