Detail

Salary
negotiable
Location
Ambernath, Maharashtra, India
Posted by: Bhavini Mamtani
22 Apr
50 Views
21 Jun expires

Development Quality Assurance (DQA)

Ambernath, Maharashtra, India
Job Description

Location: Ambernath, Maharashtra

Responsibilities:

 

  • Issuance of various documents and maintaining tracking.

 

  • Achieves Quality Assurance operational objectives by monitoring and reviewing LNB and Log Book for day-to-day activities, identifying and addressing gaps and problems and resolve the same.

 

  • Responsible for Review and Approval of protocols and reports, SOPs and Master Documents pertaining to Research and Development activities and its compliance.

 

  • Responsible for Review of Raw and Packaging Material vendor documents like DMF, Vendor information form, Process flow, Stability data, GMP certificate, TSE/BSE etc.

 

  • Support development and implementation of appropriate quality systems for MA and ANDA development activities

 

  • Perform the review of development documents for MA and ANDA submissions, including tech transfer documents, product development reports, tech pack, analytical method development/validation protocols and reports, stability protocols and reports

 

  • Responsible to provide Quality support at various stages of Product Development.

 

  • Together with Product Development, provide guidance, oversight, and direction to external partners to ensure development activities are performed in a manner compliant with regulatory expectations

 

  • Responsible for the co-ordination with Vendor, Purchase team and R&D team to resolve Development related product quality issues.

 

  • Responsible for ensuring GLP compliance in the Laboratories as per the respective SOPs of site

 

  • Ensure consistent performance of instrument and equipment by monitoring calibration and preventive maintenance which may have impact on quality of product. 

 

  • Responsible for Contract testing laboratory, Contract Manufacturing Organization evaluation and Qualification for external development / testing / manufacturing activities.

 

  • Responsible to perform audit of Raw Material Vendor, Contract testing laboratory, Contract manufacturing organization.

 

  • Should have Knowledge about QBD Software

 

  • Responsible for E software of Quality Management System
Job ID Reference
1358
Desired Skills & Experience

Qualifications & Experience

  • BPharm or MPham, BSc or MSc with 5-8 years of relevant work experience
  • Experience with vendor audit is mandatory
Company
  Thane West, Thane, Maharashtra, India
  http://alivira.co/Splash
About Alivira:
Alivira, a subsidiary of SeQuent Scientific, is a USD 150mn integrated global animal health company operating in the area of animal health with a strong presence across EU, Latin America, Turkey, Africa, India and CIS. Our operations are underpinned by comprehensive manufacturing capabilities, strict adherence to quality and compliance. We are headquartered in Thane West with manufacturing facilities based in India, Turkey, Brazil and Spain with approvals from global regulatory bodies, including USFDA, EUGMP, WHO and TGA, among others.

  Workplace
 Ambernath, Maharashtra, India
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