Ipca Laboratories Ltd – Openings for QMS / QA Documentation / Regulatory Affairs

Ipca Laboratories Ltd – Openings for QMS / QA Documentation / Regulatory Affairs

Ipca Laboratories Limited is an international pharmaceutical company based in Mumbai, India. Ipca sells these APIs and their intermediates world over. Ipca Laboratories Ltd is a fully integrated pharmaceutical company engaged in the manufacturing, marketing and distribution of Active Pharmaceutical Ingredients, pharmaceutical formulations and medicinal products across the globe. we are one of the world’s largest manufacturers and suppliers of over a dozen APIs. These are produced from scratch at fully-automated manufacturing facilities, approved by the world’s most discerning drug regulatory authorities like UK-MHRA, EDQM-Europe, and WHO-Geneva, among others.

 

IPCA LABORATORIES Ltd is looking for competent personnel to be a part of QMS, RA & Documentation in QA Department for our Formulations plant based at Pithampur SEZ

Job Responsibilities: – QMS

*Responsible for preparation of PQR.

*Responsibility to prepare / review SOPs, handling of Change Controls, *Deviations, CAPA, OOS, OOT & Effectiveness checks in Track Wise.

*To prepare quarterly and annual trend reports

*Monitoring of Site Quality-Compliance, escalation of negative trends and tracking of associated action plans.

Job Responsibilities: – Documentation

*Change control proposals

*Deviations

*Out of Specification / Out of Trends

*Customer Complaints

*Quality Investigations & CAPA

*Annual Product Quality Review

*Training

*Culture Improvement Plan

*Internal audits

*Standard Operating Procedures & Harmonization of QMS & documentation

*Analytical & Electronic Data review

Job Responsibilities: – Regulatory Affairs

*To review the Executed/Intended BMR, BPR, Protocol, batch formula, Batch Summary, flowchart and other In-process data.

*To review the analytical results w.r.t. specifications & compliance.

*To review Process Optimization, Pre-Exhibit, Exhibit and Process Validation Protocol & Reports of Drug Product.

*To prepare and review Risk Assessment of Elemental impurity for ANDA, EU and Canada.

*To review stability Protocol, Post approval stability Protocol and stability data for submission

 

Experience:- 1 – 3 Years

Qualifications:- B.Pharm and M.Pharm

Job Location:- Pithampur – SEZ

Regards

Shubham Joshi,

Ipca Laboratories Ltd.

Pithampur SEZ

shubham.joshi@ipca.com

T : 07292667008

Mob : 9911590055

E No : 108

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