Teva Quality Control Analyst 

India, Madhya Pradesh, Gwalior 

499749492

• 24 × 7 audit readiness.
• Participation in internal, external, regulatory audits.
• Ensure 100% participation in training’s against CAPA’s.
• Responsible for initiation and investigation on LIR, OOS, OOT & boarder line results and reporting them to the in-charge.
• Supporting to share required documents from QC to RA/ other requirement.
• Determining team priorities in accordance with the plant’s needs, while coordinating with the teamleader /Manger.
• Follow up the housekeeping, cGMP, GLP and Safety Guideline in laboratory.
• Sampling and analysis of RM / FG / intermediates / cleaning samples based on requirement and result entry in analytical sheet, QA form, LIMS and online documentation as per data integrity norms.
• Perform analytical test according to the monograph and SOP.
• Responsible for calibration and verification of instruments.
• Maintaining of reserved samples room and chambers / autoclaves / incubators.
• Help in preparation of documents related to department (like STP’s, SOP’s and etc.)
• Ensure the sampling of finished products, Raw material, Intermediate and sending sample to outside laboratory for analysis.
• Must be ensured sampled, approved and rejected labels timely as required.
• Responsible to maintain the stock record of chemicals and reconciliation of standards.
• Responsible to maintain safety CAPA.
• Responsible to maintain 5-S in QC.
• Online documentation (based on requirement) must be ensured as per data integrity norms and awareness to team against data integrity.
• Responsible to support analysis reduction/QC efficiency enhancement programs.
• Any other job assigned by the Manger -QC Manger or group leader-QC

Bachelor/ Master's of Science with at least 5 years of experience.

Good understanding of Quality Control, Microbiology Techniques & Understanding of GMP & GLP.