Multiple openings At Ipca Laboratories ltd For B.Sc, M.Sc, B.Pharm,M.pharm

IPCA Laboratories Limited is Hiring For Officer QMS Section in QC,Officer (QA Department) IPQA,Officer (QA Department) Regulatory Affairs and has issued notification to accept Applications.IPCA Laboratories Limited Laboratories Limited is an international pharmaceutical company based in Mumbai, India. .Application form link provided at the end of post. Eligibility for the  Officer QMS Section in QC,Officer (QA Department) IPQA,Officer (QA Department) Regulatory Affairs as follows.

Vacancy summary details :

• Company Name: IPCA Laboratories Limited
• Location : Indore, Pithampur
• Post Name: Officer QMS Section in QC,Officer (QA Department) IPQA,Officer (QA Department) Regulatory Affairs
• Qualification : B.Sc, M.Sc, B.Pharm,M.pharm
• Experience:01 – 06 years
• No of Vacancies: NA
• Details of Salary: NA
• Date of examination: NA
• Mode of application : online
• Selection Process: Shortlisted candidates may called for selection process (  Personal interview , Group discussion , etc…,)
• Contact: 07292667008 , shubham.joshi@ipca.com
  

Job Description/Skills Required: 

IPCA LABORATORIES Ltd is looking for competent personnel to be a part of QMS Section in QC Department for our Formulations plant based at Pithampur SEZ

Job Responsibilities: –

• To perform lab activity review like analytical data, change control, laboratory events, lab incident, OOS & OOC in quality control lab.
• To carry out the full-scale comprehensive investigation of Out of Specification (OOS) and Out of Trend (OOT) observed in Finished Drug Product&Stability samples.
• To carry out and ensure the implementation status of Corrective Action & Preventive Action (CAPA) and its effectiveness.
• To follow compliance of Laboratory with system SOP’s.
• Audit trail review of CDS and NON CDS instruments.
• To check the QMS of QC Department.

The candidate should have good English communication skill.

*Note: This requirement is for only QMS experienced candidates, fresher and Non QMS candidate are requested, not to apply on the post or try to contact on given Contact No..

IPCA LABORATORIES Ltd is looking for competent personnel to be a part of IPQA Department for our Formulations plant based at Pithampur SEZ

Job Responsibilities: –

• Responsible for ensuring GMP compliance at shop floor as per respective SOPs.
• Responsible for providing line clearance in Manufacturing, WH and packing area.
• Responsible for In-process checks during manufacturing.
• Responsible to perform In-process checks at different stages of manufacturing & packing as per BMR/BPR, sampling matrix/Protocol and SOP instruction.
• Responsible for collection and timely submission of Blend sample, SFG sample, FG sample, Control samples, Micro samples, swab samples, Batch release samples, Hold time sample and other samples to respective departments.
• Responsible for execution of validation study as per protocol.
• Responsible for cleaning and calibration of IPQA instruments as per SOP.
• Responsible for review of equipment generated printouts, alarm reports and PLC/HMI data as per SOP.
• Responsible to check/verify challenge study, Rejection handling at different stages of packing as per BPR, sampling matrix/Protocol and SOP instruction.

IPCA LABORATORIES Ltd is looking for competent personnel to be a part of IPQA Department for our Formulations plant based at Pithampur SEZ

Job Responsibilities: –

• 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 Certificate of Analysis (COA) of Raw Material, Packaging Material, In process, finish Product, Innovator.
• To Prepare and review other dossier filling documents like- Dissolution profile, Retesting schedule, Reconciliation sheet, Vendor address list, Residual solvents calculation and Blend Uniformity summary etc.
• Preparation and Review of Annual Report Summary for ANDAs.
• To prepare and review Risk Assessment of Elemental impurity for ANDA, EU and Canada.
• To prepare and review Risk Assessment of Mutagenic Impurity for ANDA, EU and Canada.
• Regulatory / cGMP : To maintain the compliance of Quality System in the department.