Roles and Responsibilities
Head – Quality Assurance
Msc. / M. Pharm any other equivalent Qualification
15 – 20 years - In Pharmaceuticals - Injectable
Direct Manufacturing Quality Assurance and Compliance to assure timely delivery of results to manage the company objectives and production as well as timely new product introduction. Review procedures of quality systems, validation, change control, manufacturing discrepancy investigations, cGMP/regulatory compliance, and product specifications. Participate in regulatory inspections of the Plant
Collaborate with all levels within the organization to include, Regulatory Affairs, Sales, production, R&D, Quality Control, Engineering etc. Routinely interacts with Regulatory Agencies and also be the responsible party for dealing with third party manufacturing for quality issues.
Manage the Documentation process, Critical Systems, MQA, and Compliance Managers. Also responsible for QC review and Microbiology.
Administer, review, and approve regional policies and procedures related to standard operating procedures, validation documentation, and manufacturing discrepancy reports. Provide cGMP guidance to all departments engaged in the production of pharmaceutical products.
Manage the administration of the Quality System in the Quality Organization. Develop personnel, administer budget, plan for future resource needs with regard to personnel, equipment, and facility.
Direct investigations of product complaints for manufactured products and ensure appropriate documentation. Provide technical details as required in a manner consistent with the confidential and proprietary nature of the information.
Participate in Regulatory inspections by providing information or expediting/obtaining information required by the inspectors. Schedule and conduct pre-inspection review of operations and follow-ups where corrective action is required.
Promote continual improvement taking accountability for the effectiveness of the Quality Management System.
Science Graduate with a minimum of 15 years work related experience including a minimum of five years as manager or above. Advanced degree strongly preferred.
Should have worked in Oncology and Critical care Manufacturing plant.
Should have advanced understanding in cGMPs and GLPs
Required to provide clear communication of investigational circumstances to supervisors so that proper risk management decisions can be facilitated by senior management
Ability to understand and interpret regulations and company operating procedures as they apply to medically complex adverse drug events and determine whether the events suggest a product quality issue.
Ability to interpret large amounts of safety and quality-related data and recognize/identify potential health hazards.
UG:Any Graduate in Any Specialization
PG:MS/M.Sc(Science) in Any Specialization,M.Pharma in Pharmacy
Doctorate:Doctorate Not Required
Ideal Placement and Consultants (P) Ltd.