QA Head in VXL Drugs and Pharmaceuticals

Job Posted on Aug 30, 2017
Company Name:VXL Drugs and Pharmaceuticals
Address:703 Devika Tower, Chander Nagar, Opp Surya Nagar
Near Anand Vihar ISBT
Delhi NCR, Delhi 201011
India
Contact Person:Sarita
Phone:0120 4349191
Email Address:admin@vxldrugs.com
Required in:Formulation Unit
Job Department(s):Quality Assurance
Job Title:QA Head
Qualification:B.Pharma/ M.Pharma
Job Details:To ensure compliance to Quality systems in drug product manufacturing, packaging and release of products into market.

To ensure batch manufacturing records and analytical records are reviewed for its completeness and compliance before release of the product into the market.

To ensure Product related complaints, Product failures, Deviations and Incidents are investigated, resolved as per the laid down procedure in time.

Shall be responsible for heading the QA activities of various Tablet Facilities, Pellet Facility, Warehouse & implement new changes in respective areas..

To ensure compliance to Quality systems in drug product manufacturing, packaging and release of products into market.

To ensure batch manufacturing records and analytical records are reviewed for its completeness and compliance before release of the product into the market.

To ensure Product related complaints, Product failures, Deviations and Incidents are investigated, resolved as per the laid down procedure in time.

To approve Master Batch Production Records and Batch Packaging Records.

Specification , Standard Test procedures.

To approve Change controls, Deviations, Incidents.

To review and approve all Validation Protocols and Reports.

To review and approve Stability Protocols and Reports.

To approve Art works.

To ensure appropriate controls are put in place in the drug product manufacturing wherever required.

To review and approve risk analysis wherever required.

To ensure internal audits are performed on schedule and notify the senior management for any discrepancy noticed.

To ensure cGMP training is conducted to all employees at site.

To monitor trainings are done for all the employees directly associated with manufacturing.

Authorised to issue Certificate of analysis and release for drug products intended to all markets.

Good knowledge of cGMP & GDP

Ensure compliance of SOPs and cGMP in Manufacturing area.
Regulatory Exposure:Required
Audit Experience:USFDA, MHRA, EMA, UNCST, ANVISA, HC
Experience:12 -15 yrs
Last Date:10/09/2017
Additional Details:Factory is Located in Greater Noida
Note:Please send your resume to above email address to apply for this job.





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