Department: Quality AssuranceEmployment Type: Full TimeLocation: SudairDescriptionDocumentation Management like Issuance, Distribution, retrieval and destruction of documents i.e., SOPs, Formats, logbooks, Artwork, Lists, batch records, forms etc. and all other GMP documents.Preparation, review and revision of SOPs, Policies, Lists, SMF, Quality Manual etc. and other GMP documents.Handling of QA Activities like (QMS, Vendor Management, IPQA, Validation & Qualification, QA Oversight activities, Risk Assessment etc.).To perform all batch production related activities i.e., IPQA, review of executed batch records before the release of batch.Sampling, analysis, and release of packaging materials, ensuring all documented results are according to cGMP in respect of Analytical.Handling Incidents & Deviations in laboratory, OOT, OOE and OOS.Perform verification and/or calibration of QC instruments whenever required as per the relevant SOP.To perform all batch production related activities i.e., IPQA, review of executed batch records before the release of batch.To perform review of reports of QC Chemical and Microbiological analysis i.e. HPLC, AAS, TOC, pH, Conductivity, Sterility, Endotoxin etc.Coordinate and complete activities related to training as per the Annual Training Calendar (ATC), Annual Training Plan (ATP).To coordinate and Support Internal Audit/ Self-Inspection program as per SOP.To perform any other Quality Assurance and Quality Control related activities after completion of training.To schedule and prepare/review Product Quality Review (PQR) report.Coordinate training as per the annual training calendar and provide training to other employees.Skills, Knowledge And ExpertiseBachelor's degree in pharmacy (preferable), Chemistry or Biotechnology.Master's degree in pharmacy (preferable), Chemistry or Biotechnology.Minimum 5 Year in Pharmaceutical/ Biotechnology Manufacturing Organization.More than 3 years in multi-national Pharmaceutical/ Biotechnology Manufacturing Organization (preferable).