Today, FDC carries forward the flaming spirit of its first dream, achieving accreditations from the US-FDA, UK-MHRA, MCC-RSA, and the UAE, to cite a few. FDC is a forerunner in manufacturing and marketing Oral Rehydration Salts (ORS) and Ophthalmics, and has set-up globally approved, multi-location manufacturing facilities for Active Pharmaceuticals Ingredients (APIs) as well as Finished Dosage Forms. These facilities are located at Roha, Waluj and Sinnar in Maharashtra, Verna in Goa and Baddi in Himachal Pradesh. FDC markets more than 300 products in India and exports many of these to over 50 countries.
Post: Quality Assurance (QA) - Officer- 02
Job Description
Job Description:
- Responsible for evaluation and handling of Change Controls.
- Responsible for Handling of investigations related to Deviation, Market complaints, CAPA, OOS, OOT and Incident Reporting.
- Conduct Self-inspection audits and ensuring the compliance of GMP/GLP aspects.
- Review of documents required by regulatory department.
- Review of Vendor Assessment (PM & RM).
- Processing of Export Orders
- Responsible for review of BMR and BPR and other quality system documents.
- Responsible for preparation and updation of Site Master File and Validation Master Plan.
- Review of trends of environmental monitoring and water.
- Responsible for Batch release activity in absence of Head of Department.
- To monitor utility and facility related issues in production area, especially those related to water, HVAC and compressed air.
- Perform the role of Document Controller in absence of document administrator.
- Any other Jobs allotted by Head of the department.
- Preparation and Review of Product quality review
- As a Training Co-ordinator responsible to
-Prepare Annual Training Plan in co-ordination with Head of QA.
-Schedule and coordinate the cGMP training sessions.
-Assist in the delivery of new employee orientation training.
-Assure training records are maintained for regular, temporary and contractors/consultants.
- Review of Qualification documents.
- Approval of masters, stock transfers, reprint requests and other functions in SCM system.
Candidate Profile:
Qualification: B.Pharm / M.Pharm with 3 years experience in pharma industry.
Experience: 3 to 5 years
Additional Information:
Experience: 3-5 Years
Qualification: B.Pharm, M.Pharm
Location: Verna, Goa
Functional Area: QA
Salary: INR 2,50,000 - 3,50,000 P.A
Employment Type: Full Time
Job Type: Regular
End Date: 10th December, 2015
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