The main responsibilities are as following in accordance with execution of the Quality Management Systems and compliance, which involve change control, repack/relabel tracking, complaint handling, and reporting serious adverse events.
1. Support the implementation and maintenance of the Quality System to ensure awareness and continuous education across the local organization.
2. Support the conduct of internal audits and audit to 3PL partners and suppliers when required.
3. Coordinate with stakeholders, and drive the execution of corrective and preventive actions, ensuring the timely closure of CAPA actions, including those involving 3PL partners.
4. Consolidate and track quality compliance metrics, identify and analyze gaps with targets, recommend initiatives for continuous improvement, and enforce compliance.
5. Propose initiatives for improving quality performance.
6. Handle Adverse Event reporting to meet local regulations and J&J policies.
7. Serve as a subject matter expert and provide training to the country on the quality system, auditing behaviors, complaint vigilance, and process improvement methodologies, techniques, tools, and language to enhance processes and improve business results.
8. Undertake project assignments from the line manager.
9. Drive the execution of complaint vigilance and pharmacovigilance in the country, ensuring the timely closure of product-related complaint cases and AE reporting.
1. At minimum 3-year experience in managing quality functions in Medical Device or Pharmaceutical Industry
2. Good knowledge of Good Distribution Practice (GDP), GMP and validation, demonstrated knowledge and application of QSD/GMP, ISO standards and other local regulations.