Sr. Executive QA (Lab QA)

6 - 9 Years
Kolhapur

Job Description

  • Checking up the QC analytical records and raw data for accuracy and authenticity of RM, PM, In-process, Intermediate & Finished APIs including stability & method validation / transfer.
  • Checking of the records for compliance against QC SOPs.
  • Ensure that procedures are tested in a way that takes into account the requirement of cGLP.
  • Preparation & review of documentation in view of regulatory audits like USFDA, TGA, EU & WHO.
  • To review the QC documents, reports, SOPs, OOS, OOT, QCP Change control, Deviation, incidences etc.
  • Led for self-inspection & unit operations in QC Lab.
  • Issuance & implementation of corporate documents for lab.
  • Act as training coordinator in QC Lab.
  • Software Administrator for various software in QC. 
  • Monitor & maintain data integrity.
  • Daily Reconciliation of electronic data generated for the controlled software for hard copy vs. soft copy no. of files generated etc. Data backup, restoration etc.
  • Review & compliance against market complaint or Regulatory curie.
  • Knowledge about software Quality control management system, LIMS, Chromeleon & other related softwares

Salary: Not Disclosed by Recruiter

Industry:Pharma / Biotech / Clinical Research

Functional Area:Production, Manufacturing, Maintenance

Role Category:Production/Manufacturing/Maintenance

Role:Quality Assurance/Quality Control Executive

Employment Type:Permanent Job, Full Time

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Education-

UG:B.Sc - Chemistry

PG:MS/M.Sc(Science) - Chemistry

Doctorate:Doctorate Not Required

Company Profile

Unichem Laboratories Ltd

We are a leading pharmaceutical company with an increasing focus on innovative research and developed markets. To augment our efforts in achieving our expansion and business plan we invite young and energetic people to take up responsible positions in our organisation
View Contact Details+

Recruiter Name:Samir Gaikwad

Contact Company:Unichem Laboratories Ltd

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