• studying scientific and legal documents• gathering, evaluating, organising, managing and collating information in a variety of formats• ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA)• maintaining familiarity with company product ranges• planning, undertaking and overseeing product trials and regulatory inspections• keeping up to date with changes in regulatory legislation and guidelines• analysing complicated information, including trial data

Reviewing Doc From Adl, R&D, Quality & Prod.• Life Cycle Management Through Amendments / Annual Reports.• Managing Databases And Up-Keeping Of Recording Systems• Preparation And Reviewing Of Regulatory Dmf.• Response To Customer Dmf Queries• Regulatory Response Preparation.• Ensuring Regulatory Compliance In Line With Submission Made. knowledge of USDMF/CEP- Review data for compilation.- Exposure of preparation of USDMF/CEP dossier.- knowledge of regulatory.

Must have exposure of working in a sterile manufacturing unit.• The candidate should have experience in both QA Validation and QMS.• Hand on experience in Qualification and validation of equipment, utilities, facility and systems with team management capability.• Well versed with handling the qualification and validation activities for green filed project management.• Good personal and professional management skills for coordinating with different teams across departments the group at corporate level for smooth handling of timely project execution• To review of URS, FAT, SAT, Impact assessment, Risk Assessment, DQ, IQ, OQ, PQ and other Qualification documents.• Updating / preparing site master validation plan.• To perform the FAT for applicable equipment and utilities.• Responsible for process validation and cleaning validation of different products proposed for manufacturing.

• Must have experience in the Method Validation Department as analyst or reviewer of method validation, method verification &method transfer activities.• Review of method validation and method verification Reports & Protocols.• Calibration and analysis on HPLC, GC, GC-MS, XRD, Potentiometer.• Handling of Laboratory Investigation Reports, OOS & OOT.• Monitoring of Good Laboratory Practices.