Quality Manager- for Waymade BV

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.