Wexford Laboratories is a young, growing export oriented pharmaceutical manufacturing company dealing with diverse formulations, located at Tumkur, Karnataka.
Job Title: Quality Assurance Manager
Job ID: QA Mngr/01
Job Description:
- To ensure that all validation documentation meets external regulatory and internal guidelines and requirements.
- Responsible for review and approval for processes, equipments, computer, spread sheet and analytical validation, commissioning and qualification documentation from both technical and compliance perspectives.
- Review and approval of user requirement specifications, Impact assessments, design reviews, validation protocols, validation reports, SOPs, risk analysis and Master batch records.
- Conduct periodic audits of the quality systems, operational functions and the facility to assure management that the highest levels of quality are being maintained.
- To participate actively in regulatory audits & customer audits and to responsible to make the compliance to the audit points in accordance to CGMP
- Responsible for all cleaning validation activities & update the matrix for new products.
- Qualification: B.Sc./M.Sc. Biochemistry/Microbiology/B-Pharma/M-Pharma
- Location: Bengaluru/Bangalore
Desired Skills:
- Experience in Pharma formulation unit in QA with at least 5 years of experience as QA Manager.
- Well conversant with Drugs Acts & Rules; FDA procedures; ICH; WHO-GMP.
- Ability to manage and lead a team of young analysts.
How to Apply:
Interested candidates can send their CVs at hr@wexfordindia.com
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