Quality Manager- for Waymade BV

3 weeks ago

Vadodara India Waymade PLC Full time

Job Description Responsibilities - Implementing and maintaining the quality management system - Manages, performs and reviews cGMDP investigations, quality incidents, deviations, CAPAs, change control, Risk assessment, complaints, Recall and out-of-specifications/out-of-trends (OOS/OOTs); follows up to verify effectiveness. - Support the coordination and preparation of Quality Risk Management - Development and implementation of cGMDP compliant systems, including internal SOPs, forms, templates and work instructions. - Supports the preparation and participation in the Quality Management Review - Maintain a system for distribution/logistics and product quality complaint handling ensuring timely completion and reporting including co-ordination with third party investigation. - Prepare PQR planner, ensure PQR assessment completed as per planner and prepare PQR assessment report as required. - Management for product Launch process - Management for product stability - Responsible for the preparation and maintenance for audit programme - Participate for the preparation of health authority inspection and customer audit - Develop and deliver training programs to enhance quality awareness and ensure that employees understand and follow quality procedures. Track and maintain employees traning record. - Manage third party notification process Review and approval of CMO change control, deviation - Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and that necessary corrective measures are put in place. - Prepare and execute annual quality plan as per schedule - Review of batch documentation for QP batch certification - - Backup support for Quality specialist Required skills/ competences The Quality Manager needs to have the proper skills, experience, and knowledge in GMP, GDP activities and an educational requirement of a master's degree, preferably in Pharmacy: - 10-12 years of progressive experience within the GMP and GDP quality function of the pharmaceutical healthcare industry. Experience of working with the BV market will provide a competitive advantage. - Strong communication skills and excellent in English (writing & speaking). - Integrity, able to maintain a balance between commercial decisions and maintaining compliance with quality.

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