i) Documentation (Review and Approve): - Design and development of documentation system for preparation, review and approval of documents such as SOP- s, Batch Manufacturing Record, Batch analytical record, Department Manual, Site Master File (SMF), Validation Master Plan (VMP) etc. - Reviewing and approving all procedures, validation documents and qualification documents. - Making sure that Validation Master Plan is effective to cover all the qualification, requalification and calibration activities are conducted within due dates. - Releasing manufactured batches after proper review of Batch Manufacturing Record and Analytical records. - Implementation of document retention policies to retain Master Documents, Validation documents as well as filled documents. - Providing various declarations / statements as per customer requirement. - Filling Vendor Questionnaire appropriately and submit to customers. - Reviewing and Approving quality agreements. ii) Quality Management System: - Implementation and maintaining of cGMP in all areas such as manufacturing, testing, warehousing, releasing and dispatches etc. - Handling market complaints, preparing investigation reports and taking appropriate corrective and preventive actions. - Conducting Product Quality Review (PQR) to ensure consistency of process. - Implementation of deviation handling system to investigate, review and approve deviations happened during testing, manufacturing warehousing etc. - Implementation of change control system to initiate changes, review and approval of changes before implementation. Evaluation and closure of changes with conclusion. Notification of changes to customers and regulatory authorities. - Implement Out Of Specifications (OOS) investigations procedure. Conducting investigations and CAPA implementation. - Implement Product recall and Mock recall procedures and maintain appropriate records. - Making sure that, rejected and returned goods are handled as per procedure. - Making sure that Corrective actions and preventive actions taken are adequate. - Taking QA rounds in warehouse, manufacturing and testing zone and ensure compliance of GMP in day today activities. - Performing risk assessment studies and maintaining record. iii) Audit and compliance: - Company presentation to customer and regulatory auditors. - Conducting service providers site audit and make them approved. - Handling Regulatory as well as Customer audits as per plan and satisfactory closeout for the observations if any. - Conducting internal audits (self-inspection) in all departments as per plan and improving performance and growth of organization. - Conducting site audits of key material suppliers, service providers and maintaining records. - Third party manufacturing sites audit preparation as per requirement. iv) Qualification and Validation: - Making sure that all instruments and equipments are properly qualified and related documents are available and approved. - Making sure that all major utilities water system, HVAC, compressed air etc. are qualified and records are available and approved. - Making sure that manufacturing procedures, cleaning procedures and analytical procedures are validated and records are available and approved. v) Training - Making sure that training procedure is appropriately designed and as per that training programs are planned and conducted to all employees. - Conducting cGMP training sessions in all areas and update employee knowledge regularly. - Making sure that all analysts are qualified to perform analysis. vi) Supplier Development and Service Provider Approval - Performing Supplier development, Qualification, evaluation and re-evaluation. - Conducting cGMP audits to key material suppliers, contract testing laboratories and based on visual inspection and audit compliance report approving them. - Making sure that all service provider agreements are in place. vii) cGMP Implementation: - Implementation of Quality Management System in Pharma industry. - Initiated and developed Quality Control Laboratory System and related documentation. - Initiated and developed Quality Assurance system and related documentation. viii) Manpower handling and work management - Capable of handling of Quality unit comprising of 37 members.

Mumbai

Head - Quality Assurance/Quality Control - Active Pharmaceutical Ingredient 

Head - Quality Assurance/Quality Control - Active Pharmaceutical Ingredient  ,Job Description for Head - Quality Assurance/Quality Control - Active Pharmaceutical Ingredient  in Randstad India in  Mumbai for (15-18) years of experience. Apply Now!

Job Description for Head - Quality Assurance/Quality Control - Active Pharmaceutical Ingredient  in Randstad India in  Mumbai for (15-18) years of experience. Apply Now!