Western Drugs Pvt. Ltd. is working towards excellence since inception in 1989. The Company started production of two bulk drugs viz. Niacin (Nicotinic Acid) and Niacinamide (Nicotinamide) and is committed for total customer satisfaction by providing Quality Product to our customers dealing in Food and Pharmaceutical Industries.
They are certified for their Quality Management System: ISO 9001 : 2000 and honoured with WHO-GMP Certificate.
Post: Senior Manager in Quality Assurance
Job Description:
1.) Approval, control and distribution of quality documents like SMF, Quality Manual, SOPs, Validation protocols and reports, Specifications, Method of Analysis and General test procedures.
2.) Good knowledge in Standard Operating Procedures for all departments and reviewing of new process proposals, review of Batch Production records, and Review of cleaning records, Reviewing of Equipment qualification protocols and Reports, Change controls, Deviations, and maintenance of Change control & Deviation log books. Review of SOPs, Non-conformances, Process deviations, Change controls, Market complaints and Product quality review data on regular basis.
3.) Reviewing of Process validation protocols & Reports, Drying validation protocols & Reports, Cleaning validation protocols & Reports and maintaining validation log books..
4.) Annual Internal Audit schedule and conducting the Internal Audits, On-line audits for all the departments as per the Schedule; Compilation of the Audit reports and ensure that the non-Conformities are closed out properly.
5.) Conduct Annual Product Quality Review
6.) cGMP / HACCP training schedules and conducting the Training programs on cGMP and related activities for all the personnel involved in Manufacturing and testing of APIs and/or Intermediates
7.) Investigation of Out Of specifications and to take the necessary Corrective and Preventive Actions. Conducting training programs to the junior staff in QA.
8.) Reviewing completed batch production and laboratory control records of critical process steps before release of the API for distribution.
9.) Ensuring complaints are investigated and there CAPA is implemented. Ensure timely support for DMF/ Tech packs / deficiency response to RA. Ensure proper system for archival and retrieval of documents.
10.) Manage Customer Quality Audits and prepare and execute CAPA actions in timely manner
11.) Responsible for implementain of Good Laboratory Practices in the Laboratory.
12.) Candidates interested and willing to migrate to Udaipur shall only apply.
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Candidate profile:
a.) Qualification: Candidate should be Minimum Post Graduate in Pharmacy / Chemistry / Micro Biology.
b.) Experience: Candidate should have atleast 10 Years in Quality Assurance functions and Regulatory Affairs. The candidate must have worked for Analytical for atleast 5 Years before
c.) Candidate Should be from Pharma API Industry
d.) Candidate should have sound knowledge about
1.) Drugs and Costmetics Act
2.) WHO-GMP
3.) ICH
4.) US-FDA
5.) EU-GMP
6.) FAMI-QS
7.) HACCP
8.) REACh compliances
e) Candidate should have a good success track record
f.) Qualitative experience :
• Must have faced international audits like WHO Geneva, South Africa-MCC, etc. in a leading role
• Should have an experience of closely working with Regulatory Affairs
• Should have strong Analytical Skills; Knowledge of QA, QC analysis and interpretation of results, cGMP and GLP Analysis and Trouble shooting in analysis
Additional Information:
Experience: 10-15 years
Location: Udaipur
Education: M.Pharm, M.Sc-Chemistry, Microbiology
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QC
End Date: 7th July, 2012
To Apply/Send resume at, infoudaipur@westerndrugs.com
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