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19/06 Kalpana Gandhi
Owner at Corporate Search

Views:118 Applications:13 Rec. Actions:Recruiter Actions:0

Senior Manager - Quality Assurance - Formulations - Pharma (10-15 yrs)

MP/Indore Job Code: 3441

Corporate Search has been retained to recruit the following

Senior Manager - Quality Assurance - Formulations

Job Description

Implementation of QA systems to ensure compliance as per SOP's.

Evaluation & approval of master documents pertaining to various departments.

Timely readiness for any external and internal audits.

Preparation of the compliance report following the external audit and corporate audit and ensure compliance

Ensuring timely evaluation, approval and closure of incidence, deviations, OOS, OOT, CAPA and change controls.

Management of quality management system for OSD (Immunosuppressant / General) and injectable blocks.

Responsible for providing timely support to external and internal customers as per requirement.

To discuss warning letters, GMP trends, other sites audit report, Major incidences with stack holder.

To Share the Monthly report to CQA, Head quality and other department heads.

Review, evaluation and approval of Document on behalf of QA Head / Head Quality in his absence at location.

Responsible for approval of analytical documents as per requirements.

To plan and coordinate activities related to Injectable block.

Review and approval of master and executed BPR of injectable block.

To perform any other activity as assigned by Head Quality Assurance.

To follow cGMP practices and authenticity of the information recorded.

Responsible for review and approval of equipment qualification/ requalification/ validation protocols, compilation of summary reports of injectable block.

Responsible for support to production and R&D for TT of new product execution at site.

Responsible for ensuring Analytical Report Review Management

B Pharma / M Pharma with 10 - 15 yrs of exp in quality assurance with MNC pharma companies with good knowledge on GMP, OOS OOT audits, investigations, compliance, quality management from MNC Pharma companies.

Position is based at Indore

Comp range - 15 lakhs - 30 lakhs

Relevant candidates interested may apply to with a brief introduction and compensation drawn

Seema Gandhi

9820877605

Kalpana Chhatriwala

CorporateSearch

98200-53879

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