Glenmark Pharmaceuticals | General Manager Quality | mumbai
2 weeks ago
Responsibilities:
Develop and manage audit programs for new and existing Contract Manufacturers (CMOs), support technology transfers to CMOs and maintain and manage CMO related documentation.
Ensure that expenditure on audits is within budget. This shall be achieved by advance planning, clubbing audits in same geography, remote audits - after assessing risk.
Develop quality strategy for LL, TP sites based on the compliance risk and business risk.
Maintain an active surveillance of products within scope and ensure reputation of Glenmark is protected at all times.
Control testing costs by negotiation with PTL, clubbing tests together
Reduction in product quality issues through CIP & timely support from R&D
Introduce best industry practices at CMOs by periodic trainings & continuous monitoring
Regularly update vendor SOP for compliance & best industry practices
Successful regulatory inspections at CMOs & Nasik, without any critical observations
Reduction of invalid OOS & lab incidences
Ensure adherence to agreed SLA for testing & release of batches. Also make sure new product launches are within accepted timelines
Evaluate repeat complaints and or quality issues & initiate suitable CAPA
Ensure AVD proposals are handled & closed in time
Effective utilization of SAP / Track Wise / GYAN for process simplification & effective utilization of resources in VM team
Enhance in-house testing capabilities to reduce dependence on external labs
Prepare and execute robust vendor / supplier management program. Develop and manage a global audit program of existing API excipient, key raw materials and packaging materials vendors based on the risk evaluation and scoring input from the sites
Perform audits of new vendors as per request from R&D Quality, site Quality or other functions to ensure vendor’s quality systems are effective and meet standards.
Knowledge and Skills ( Functional / Technical )
Experience in handling Quality Assurance elements in the area of contract manufacturing.
Regulatory Authorities Exposure, USFDA Audits
Awareness of Manufacturing Processes, Business Processes & Quality
Leadership/ Managerial Attributes
Excellent Leadership and team management skills
Very high level of ethical conduct and integrity
Strong decision making abilities
Excellent communication, interpersonal and influencing skills
Strong attention to detail and Quality focus
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