Laboratory Validation Chemist

**Division: CIPLA Mirren**:
**Department: Quality Control**:
**Job Purpose**:
The 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 Interactions**:
All internal departments (Engineering, Quality Control, SHERQ, Finance, Supply Chain, Admin

**Education Qualification**:
National Diploma / BTech Degree and or B.Sc. in Analytical Chemistry/Biotechnology

**Relevant Work Experience**:
4-7 years in a laboratory environment.