Manager - QC - Oman Pharmaceutical Products Co., LLC - Oman
(2012-06)
A UKMHRA, BGV (Hamburg), USFDA, WHO-GMP, ANVISA, GCC, MCC, and TGA approved pharmaceutical formulation company. Manufacturing solid oral dosage, ointments, creams and dry syrups.
- QC Functions: Overall responsibility of QC-Finished products, RM, PM and Stability departments to coordinate with Section-heads for daily work plans, and closely following with the production department to fulfil day-to-day plannings while adhering strictly to GMP and current good laboratory practices.
- Investigations: Investigation and Compilation /Closure of all Incidents, OOT, OOS, CAPA, and deviations generated in Quality control Laboratory.
- Approvals: Review and approval of Standard Test Procedure & Specification for Finished Products & Raw Materials.
- Authorization: Review & Authorization of Raw Material, Packing Material Finished Product and In-Process sample result in ERP system.
- Cost reduction: Reduce errors, Reduce rework, waste. Developing short run time in HPLC analysis. Improve delivery performance.
- Trainings: Directing inductions and specific training of staff/trainee, working in the Quality control department.
- Audits: Involving all QC related internal/External/Regulatory audits and on time closer of the audit observation reports.
- Regulatory support: Leading in Regulatory/Customer audit preparation.
- Change control: Coordination and follow-up of change control procedures.
- QC Instruments: Monitoring of maintenance and calibration schedule of all QC instruments and its implementation.
- Investment programs: implementing new methods in the quality control department to meet daily production goals more quickly.
Group Leader - ADL - Famy Care Ltd - Mumbai, India
(2009-05 - 2012-05)
- To carryout Analytical Method Validation of Hormonal products by HPLC.
- Review of SOPs, Specifications, STPs, GTPs, and Stability Protocols.
Sr. Executive-ADL - Natco Pharma Ltd - Hyderabad, Telangana, India
(2006-02 - 2009-05)
- Responsible for involving regulatory audits as part of ADL department.
- Preparation of method validation protocols and reports.
- Analytical method validations using HPLC and other instruments.
Sr. Executive-QC - Aurobindo Pharma Ltd - Hyderabad, Telangana, India
(2001-10 - 2006-02)
- Analysis of Finished products by HPLC.
- Initiation of Analytical method tech transfers.
Analytical Chemist - Trident Pharmaceuticals Ltd - Hyderabad, Telangana, India
(1998-06 - 2001-10)
- Sampling of raw materials, testing of in-process and finished product samples.
- Preparation of reagents, indicators, volumetric solutions and standardization.
- Analysis of raw materials and packing materials.
