Prahas Healthcare Llp

• Salary:
• Location: Vadodara
• Key Skills: Accounting

Job Description:

Job description Position Summary We are looking for a Young & Dynamic Quality Control Professional with Sound Knowledge & Industry Expertise in In Vitro Diagnostics (IVD) Manufacturing to handle Quality Control Operations, Analytical Testing, Laboratory Activities, Product Evaluation, and Quality Monitoring related to IVD Products and allied Diagnostic Manufacturing activities. The candidate will be responsible for managing the QC Department, supervising the QC team, ensuring compliance with GMP, GLP & ISO 13485 standards, and will be reporting to the Head of Quality Control. Job Skills Active Listener & Detail Oriented. Able to do effective communication with internal & external stakeholders. Must possess Decision Making Skills. Leadership and Team Management abilities. Strong Knowledge of IVD Quality Control Processes & Laboratory Operations. Hands-on experience in Diagnostic Reagents / Rapid Diagnostics Testing. Knowledge of GMP, GLP & ISO 13485 requirements. System / SOP Implementation Abilities & Experience. Software: Microsoft Office Word Advance Excel PowerPoint ERP Systems. Knowledge of Laboratory Documentation, Batch Testing & Traceability Systems. Ability to handle OOS, OOT, Deviations, CAPA & Investigation Activities. Key Responsibilities Team Management & Team reviews and providing direction for daily Quality Control activities. Handling Quality Control Operations related to IVD Products, Diagnostic Reagents, Rapid Diagnostic Components & allied manufacturing activities. Performing and supervising testing of Raw Materials, In-process Samples & Finished Products. Monitoring Laboratory Operations and ensuring compliance with approved SOPs, GMP, GLP & ISO 13485 requirements. Reviewing Analytical Reports, QC Documentation & Traceability Records. Handling OOS (Out of Specification), OOT (Out of Trend), Deviations & Investigation Activities. Conducting Stability Studies, Method Validation & Analytical Verification activities. Ensuring Calibration & Maintenance of Laboratory Instruments and Equipment. Coordinating Batch Release activities with QA & Production Departments. Maintaining Laboratory Documentation, QC Records & Product Traceability Systems. Handling Internal & External Audits related to Quality Control Department. Training QC Team on SOPs, Laboratory Practices & Quality Procedures. Ensuring Safety, Cleanliness & Discipline within Laboratory Areas. Managing Quality Monitoring activities and Continuous Improvement initiatives. REMUNERATION: (CTC IN INR) Will Depend on Candidates Experience & Performance in the interview, hence no bar for the right candidate. Role: Healthcare & Life Sciences - Other Industry Type: Medical Devices & Equipment Department: Healthcare & Life Sciences Employment Type: Full Time, Permanent Role Category: Healthcare & Life Sciences - Other Education UG: B.Sc in Biochemistry, Microbiology, Biotechnology PG: MS/M.Sc(Science) in Biotechnology, Bio-Chemistry, Microbiology Key Skills Skills highlighted with ‘‘ are preferred keyskills Quality Control OOS InvestigationIVDQC TestingGLPGMPAnalytical TestingQuality Documentation