- 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:Quality Assurance/Quality Control Executive
Employment Type:Permanent Job, Full Time
Desired Candidate Profile
UG:B.Sc - Chemistry
PG:MS/M.Sc(Science) - Chemistry
Doctorate:Doctorate Not Required
Unichem Laboratories Ltd
Recruiter Name:Samir Gaikwad
Contact Company:Unichem Laboratories Ltd