Accountable for effective operations of FFP for bacterial and recombinant vaccines, viral vaccines and therapeutic drugs
Responsible for FFP production schedule to meet the commitment to the supply chain management department.
To develop the people to train, organize and recruit in alignment with overall company
Responsible for timely completion of projects to meet the company objectives.
Responsible to prepare the team for various regulatory inspections/ audits and GMP Compliance.
Responsible to build good working relation with cross functional and interdepartmental teams.
Ensure continuous improvement of Industrial Performance in the FFP area.
Ensure anticipation of investment, Budget planning and its effective utilization including CAPE.
Improving and approve the instructions relating to
production operations and ensure their strict implementation (SOPs, Batch production records etc.
Responsible for the all maintenance and validations for facilities, premises and equipment in compliance with current GMP recommendations in FFP. Ensure setting of quality standards, Resource Planning, GMP implementation and be part of Failure Investigations and Crisis Management for FFP.
Ensure the implementation of HSE practices in FFP in accordance with the site HSE policies
Improve the existing faciIity in terms of equipment, premises
Exposure in handling deviations / change controls
Good knowledge in eGMP, qualifications, SOP preparation, quality management systems.
Wide experience in formulation and filling of vaccine's / injectable's
Experience in environmental monitoring activities
Experience in combination vaccine formulation and therapeutic drug formulation
Good knowledge of CGMP, process validation, SOP preparation.
Good working knowledge of the SAP or equivalent ERP system Very good knowledge of Compliance to quality management system procedure.
Qualification: M.Pharma ( Pharmaceutics) / M.sc (Microbiology/ Biotechnology)