Highlights:

Skills:In process Quality Inspector, APQR/APR/PQR, Vendor Audit, QA Documentation

Sr. Executive QA 09/03/2015 - current
Wockhardt Limited, Mumbai, Maharashtra India
Industry: Pharmaceutical
Working in Wockhardt’s Domestic business in Corporate Quality Assurance department. Coordinating with various contact manufacturers with respect to Quality aspect of Medicinal product manufacture at respective site for Wockhardt Limited.
To perform Quality Audits of the Third manufacturing parties. To monitor Product Transfer activity between TPM sites. Inspection / Audit of warehouse, hub, carry and forwarding agent locations. Scheduling and co ordination for Quality Audit, Re-Audit & its compliance. Preparation of Standard operating procedures (SOP). To perform Product Surveillance Study of marketed product. Review of Analytical reports received from Public testing laboratories. To coordinate with vendors, Site QA, Public testing laboratories. To follow up with the vendors for audit compliances, CAPA on Quality complaint and Incidents. Review of Analytical reports, APQR, CAPA received from sites. Review and approval of primary & secondary packaging artwork. Audit Re-audit of Public testing laboratories.--
Officer QA 09/2013 - 02/2015
Watson Pharma Pvt. Ltd., Madgoan, Goa India
Industry: Pharmaceutical
Working in Quality Assurance department of the Manufacturing Unit of Watson Pharma Unit IV. Responsible for In-process Quality Checks and control of cGMP during manufacturing of the Drug Product. Member of APQR team. Shift In charge of QA Team.
To perform In-process Quality Assurance checks. To give line clearance before starting batch at every stage of manufacturing. Preparation of protocol and reports for Transportation Study, Standard operating procedures (SOP), Annual Product Review (APR). To review executed Batch Manufacturing & Packing Record (BMR/BPR), Preparation of product quality review for the year, Transportation Study Protocol. Sampling of Cleaning/Process validation samples, In-process and Finished Product, reserve samples. Batch release through SAP for in-process and finished stage.--
Executive QA 01/2010 - 09/2013
Genpharma Internaltional Pvt. Ltd., Pune, Maharashtra India
Industry: Pharmaceutical
Working in Quality Assurance department of the Manufacturing Unit of Genphrma International Pvt. Ltd. Responsible for In-process Quality Checks and control of cGMP during manufacturing of the Drug Product. Member of APQR team. In charge of QA Team, QA Documentation.
To perform In-process Quality Assurance checks. To give line clearance before starting batch at every stage of manufacturing. Issuance and retrieval of executed batch manufacturing records (BMR). Preparation of protocol and reports for process validation, stability, master formula record (MFR), batch manufacturing record (BMR) Standard operating procedures (SOP) , Annual Product Review (APR). To review executed batch manufacturing record. To maintaining training record of all employee. Handling of Change control, Deviation, Out of specification & Out of trends reports. Reviewing of printing artwork on aluminum foil, printed carton. Preparation of product quality review for the year Sampling of Process validation samples, In-process and finished product. Executing Cleaning Validation Project. Handling of legal documents for regulatory purpose like FSC, COPP, manufacturing License, etc.--

Maharashtra State Board of Secondary & Higher Secondary Education 05/2002 - 06/2004
Pune, Maharashtra, India
Degree: High School Or Below
Major:Science
Completed Higher Secondary Education in Science field with First Class.

Jaydeep Phalle Pharma QA Documentation QA