Executive, Quality Control - Aurobindo Pharma Ltd - Unit – X, Naidupeta
(2017-03)
Approvals: USFDA, MHRA-UK, WHO, MCC, TGA
- Review of In-process, Finished product, Process validation and Hold time study samples for analysis in LIMS
- Planning of In-process, Finished product, Process Validation, Hold time study samples
- Sporting empower review and sigñ off for the analytical activities in analytical method transfer, method verification and cleaning validation as and when required
- Timely submission of completed analytical reports to Manager
- Reporting the OOS, OOT, non-conformance and participate in the investigation
- To follow and ensure GLP compliance in the laboratory as per written down procedures
- To follow general test procedures, standard testing procedures and standard operating procedures as per written procedures
- To follow and ensure safety compliance as per written down procedures
- Responsible for checking and updating of all QC log books and maintain a state of readiness for audit at any time
Quality Assurance Officer - Cipla Ltd - Goa
(2007-05 - 2010-10)
Formulation: Tablets/Capsules/Pellets/Multihalers. Approvals: USFDA, MHRA-UK, WHO, MCC, TGA
- Responsible for in-process inspection during manufacturing & Packing
- Checking online documentation as per c-GMP
- Reviewing of Draft and Executed BMR's and BPR's for Regulatory submissions
- Preparation, review, planning, monitoring, execution and Compilation of process validation and ANDA batches
- Review and Compilation of Hold Time Study Protocol and Report
- Preparation and review of other auditable documents
- Co-ordination with QC, QA and maintenance, for quality production
- Hand on experience in the routine production activities like manufacturing, compression, Filling and Coating
- Handling of Change control, CAPA, Deviations related to process and packing
