Job Description

Division: CIPLA MirrenDepartment: Quality ControlJob PurposeThe incumbent is responsible for planning, drafting protocols, execution and final reporting approval of Analytical Method validation (AMV), Analytical Method transfer (AMT) and Process Validation (PV) / special request (non-routine) samples in accordance with procedure.Key Accountabilities (1/5)

• Provides support to quality control and manufacturing for resolution of analytical and quality related problems
• Works on Tech transfer projects.
• Responsible for ensuring GAP analysis and risk assessments are submitted on time for tech transfer products
• Drafts all protocols related to Analytical method development, method transfer, cleaning validation methods and method verification.
• Prepares tracker for AMD, AMV and AMT to be performed and report on progress on Monthly basis.
• Execute all protocols as per plan and tracker.
• Ensure staff is trained on the procedures.
• Logs CAPA, Deviations and Change controls and ensure they closed within stipulated time frame.
• Implements activities to prevent recurring of OOS and OOT attributed to QC function
• Trouble shooting
• Responsible for ensuring the integrity of all data and documentation reported from the Chemistry Laboratory.
• Reviews all source data for conformance to applicable specifications.
• Facilitates data or documentation corrections with analysts to ensure all records are complete and appropriate references are made.
• Ensures investigations are assigned, completed and referenced for data or documentation, as appropriate, prior to release of Chemistry data.
• Interacts routinely with departments such as Production, RA, R&D, QA Validation team
• Assist in performing Quality Assurance audits on laboratory areas to ensure cGMP compliance.
• Assist in the investigation and review of deviation reports and OOS reports to assure complete and compliant source data.
• Assist in training and mentoring junior analysts on the interpretation of data and use of electronic data systems.

Key InteractionsAll internal departments (Engineering, Quality Control, SHERQ, Finance, Supply Chain, AdminEducation QualificationNational Diploma / BTech Degree and or B.Sc. in Analytical Chemistry/BiotechnologyRelevant Work Experience4-7 years in a laboratory environment.

Cipla