Senior Manager/ Deputy General Manager

  • Vadodara
  • Confidential
  • 14-24 years
  • Views
  • 26 Apr 2018

  • Production/ Manufacturing/ Engineering

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Position - Sr Manager/DGM QC - API Job Location - Dabhasa, Near to Vadodara - Gujarat Qualification -, M.pharma Experience - 15 Year + Candidate should have good experience in QC dept in API plant.  Role Description - This position is responsible for overall QC function at the site. This position works closely with other organizational functions (Manufacturing, procurement, RA, R&D, PDL, ADL, PQA, CQA etc.) for ensuring timely support to Supply chain while ensuring quality & compliance. Ensure the compliance to written procedures in routine quality control operation. Continuous improvement in quality system to improve overall compliance in line with the GMP /GLP & regulatory expectations. Ensure agreed service level agreement on analysis is met consistently to achieve site deliverable. Trouble shooting of instrument related issues and timely resolution by co-ordination with the service engineer. Perform periodic gap analysis and ensure implementing of identified improvement on laboratory compliance. Review of specification, STP, TDS, Protocols, analyst qualification and analytical method validation documents and ensure compliance. Investigate laboratory incidents, OOS, OOT and deviations timely and ensure appropriate CAPAs are implemented. Ensure compliance in the aspects of calibration, preventive maintenance and any breakdown maintenance of laboratory instruments and equipment. Review of the change controls pertaining to QC function and ensure risk assessment are performed wherever requirement in compliance to the established standard operating procedures. Release or rejection of materials and products subject to the compliance of quality system. To ensure that the required initial and continuing training of all dept. personnel is carried out and adopted according to the need. Training of dept. personnel on the principles of good laboratory practices and Good manufacturing practices. Facing Regulatory and customer audits of the sites. Job Specification - Has experience of working preferable in API QC. Candidate must have knowledge of overall monitoring, planning, trouble shooting and co-ordination with other dept. for smooth functioning of quality control laboratory. Has capabilities to ensure the compliance of written procedures in routine working, gap analysis and implementation of improved quality system to ensure the overall compliance in laboratory i.e. continuous evaluation of Quality systems. Sound knowledge of QC instruments e.g. HPLC, GC, PSD analyzer, UV FTIR, ICPMS, XRD, TGA etc. Has sound knowledge on AMT, AMV. Has faced and well aware of USFDA, TGA, EDQM / other regulatory audits. Adequate knowledge on Good Chromatographic practices, Audit Trail, Back up, Controls on Standalone instruments etc. Have knowledge for review of specifications, STP, TDS, protocols, Analyst qualification documents, method validation and latest chromatographic procedures etc. Have direct exposure / experience of handling of incidences, OOS, OOT, CAPA, Change control, deviation and failure investigation. Candidate must have knowledge of qualification / calibration, preventive maintenance of instruments/equipments/working standard management as per latest guidelines. Have knowledge to impart training to quality control personal on QC procedures, principles of good manufacturing practices and good laboratory practices. Have experience of handling / motivating and leading of a team having strength of around 50-60 people.

Competencies/Skill sets for this job

Qc Quality Control

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