Overall purpose of job:
Major responsibilities are as following in accordance to STD, SOP, GMP, QSD related standards, and local Regulatory requirements.
Essential duties and responsibilities:
- Support to implement and maintain Quality System to ensure awareness and continual education across the local organization.
- Support to conduct internal audit, audit to 3PL and suppliers if required.
- Coordinate with local team and lead; drive the execution of corrective action and preventive action, ensuring the timely closure of CAPA actions, including 3PL partners.
- Consolidate and track the quality compliance metrics, identify, analyze the gap with target, recommend initiatives for continuous improvement and compliance enforcement.
- Support to the site management review.
- Propose initiatives for quality performance improvement.
- Drive for complaint vigilance execution in the country ensuring the timely closure of product related complaints cases
- Handle Adverse Event reporting to meet local regulation and J&J policy.
- As a subject matter expert, train country in the QS system, auditing behaviors, complaint vigilance and process improvement methodologies, techniques, tools, language etc. to improve processes and improve business results.
- Project assignment from the line manager.
- Prefer 2 years experience in managing quality functions in Medical Device or Pharmaceutical Industry
- Thorough knowledge & understanding of QSD/GMP regulations, !SO standards & local regulations
- Strong leadership, influence, collaboration, and interpersonal skills.
- Knowledge of GSP, GWP, GDP, [SO and Quality Systems.
- Analytical and process oriented with an interest/aptitude in operations.
- Communication and presentation skills
Johnson & Johnson Medical Taiwan Ltd. (8582)