About Company:
Emcure Pharmaceuticals Ltd. (EPL) is an Indian pharmaceutical company headquartered in Pune engaged in developing, manufacturing and globally marketing a broad range of pharmaceutical products across several major therapeutic areas. Established in 1981, EPL is ranked as the 11th largest company in Indian Pharmaceutical Market as per AWACS MAT Feb’24 data.
Website
https://www.emcure.com
Vacancy Details:
Job Description:
We are Hiring!!!
Emcure Pharmaceuticals Limited is looking for dynamic professionals for quality department at our Sterile manufacturing unit – Sanand.
Designation:- Manager/ Sr. Manager
Department:- Quality (Investigation team)
Job Responsibilities:-
1.Compliance & Documentation: Ensure adherence to cGMP, GLP, regulatory requirements, and approved SOPs; review quality system documents like deviations, CAPA, OOS/OOT, and market complaints.
2.Investigation Management: Lead, plan, and document investigations (OOS, market complaints, validation issues), conduct root cause analysis, and prepare clear, concise technical reports.
3.Batch Release & Quality Oversight: Approve or reject product batches in SAP, handle product recalls and field alerts, and coordinate with customers on quality-related inquiries.
4.Risk Assessment & CAPA Implementation: Assist in risk/impact assessments, identify and implement effective corrective and preventive actions, and ensure their approval and execution.
5.Training & Team Coordination: Provide training to subordinates and peers as needed, conduct personnel interviews for investigations, and coordinate with functional leaders on deviations and escalations.
6.Audit Readiness & Additional Duties: Represent the unit during audits/inspections, ensure timely closure of deviations, escalate issues when necessary, and perform tasks assigned by HOD.
Candidates having experience in Injectable Facility and meeting above requirement may share their cv in pdf format along with other details on below mentioned Mail Id with Subject line ‘LinkedIn_QA_Investigation”
Mayur.Desai@emcure.com
Ditee.Thakar@emcure.com