Full Description

Job Responsibilities

Responsible for review, compilation and approval of Deviations, Incidents, Change Control and Root Cause Analysis. Responsible for review and approval of SOPs. Responsible for review, approval and proper implementation of CAPA Responsible for participating in vendor Audits, ensuring Vendor Qualifications are performed as per SOP and availability of updated Approved Vendor Lists. Responsible for review, approval of Artworks of finished product Labels, Leaflets and Mono-cartons. Responsible for conducting and preparation of Self-inspection reports and ensuring the observations closed in timely manner. Responsible for handling of Market Complaints & Product Recall. Responsible for providing trainings. Responsible for approval of Certificate of Analysis, Specifications, STPs and SOPs. Responsible for review and approval of approved vendor list of RM & PM. Responsible for review the executed copy of BMRs & BPRs. Responsible for approval of Batch release certificate of finished products. Responsible for the allocation of equipment, instrument, facility, documents numbering. Responsible for maintaining all documentation are online with respect activities. Responsible for management of control sample and stability samples. Responsible for preparation and compilation of reports like Area Qualification, Equipment Qualification, Utility Qualification, Process Validation etc. Preparation and Review of SMF, VMP and Quality Manual. Biologics experience mandatory. Show more Show less