Job Description

Role & responsibilities Lead a team of QA professionals to manage QA oversight to Manufacturing process operations. Provide leadership for lot release, incoming quality, manufacturing, and labs investigations, change control and corrective and preventative action review/approval, manufacturing support, record review/approval, and ongoing projects support etc. Support team by guidance and coaching and provide direction/approval of activities and decisions. Coordinate planned external audits and drive Internal Audit plan and share reports and outcome to the Site Management Team proposing continuous improvement action plan Analyze trends, quality metrics and other data to identify quality and compliance gaps. Manage release of product batches, including owning the QA product release workflow in SAP. Develop and maintain a Quality Management System in accordance with domestic and international regulatory requirements Manage Quality Control related activities regarding all in-process checks, deviations, RM release, and finished product release. Ensure that products conform to specifications and regulatory requirements. Approve or reject all formulations, procedures, specifications, test methods, raw materials, packaging materials, and finished products, including products manufactured at third parties , based on conformance / non-conformance to respective specifications that affect the purity, quality, and composition of each product. Oversee complaint handling, corrective and preventive actions, internal audit program, supplier quality assurance, product inspection and release, equipment calibration, and control of nonconforming material. Maintain Master formulations, Change Control, and history records. Develop & make a master formula for all new registrations. Identify and analyze issues related to in-process manufacturing and resolve them. Maintain and improve product quality by completing product and company system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop a new product, and manufacturing and training methods. Responsible for periodic review of SOP s, specification and standard operating procedure. Responsible for trouble shutting of analytical instruments. Responsible for Quality training initiative (GMP) across the site. Candidates must have experience HVAC validations . Candidates must have experience in microbiology sections . Candidates must have experience in handling of BMR, BPR,IPQA. Candidate worked regulatory environment like WHO-GMP, MHRA,EU-GMP etc. Candidates must have experience FDA license registration process Candidates must have experience in dossiers preparation.