Bring In Technology Limited
We focus in Consumer Electronics Supply Chain Management Service to overseas clients. We provide ODM and OEM service to customers. We are a profession team with in-house technical resources and test facilities to evaluate product development from design, prototyping till mass production stages. To cope with our operation expansion, we are looking for the candidates to support our business growth.
Compliance Manager (FDA products)
jobsDB Ref. JHK100003004916042
Employer Ref. BIT-01Q42016
- A sound understanding of quality requirements with extensive experiences on quality document system formation and auditing with pharmaceutical and / or medical device products to drive for factory improvment
- Understanding of production lot control and tracebility processes and recording system
- Strong leadership role in defective root cause analysis and corrective action recommendations by collaborating with different stakeholders
- Collaborate with departments to ensure validation and compliance activities are executed efficiently and effectively, and in accordance with all governing documents and external guidelines.
- To plan and conduct continuous on-site audit ensure the documents in place are exactly followed in factory
- Regulated service provider vendor management such as pest control, bacterial control and water quality control.
- Contribute to continuous quality improvement efforts to conform to regulatory requirements and industry standards.
- Ability to make sound GMP decisions, allocation of resources, and managing priorities
- Ability to communicate clearly and professionally both in writing and verbally in both Mandarin and English.
- Ability to work independently and cross-functionally in a dynamic environment • Robust understanding of CAPA and NC protocols, standard practices, and root cause analysis investigation techniques.
- Degree holder science and/or engineering related, and at least 3 years of experience in the pharmaceutical or bio-pharmaceutical industry, or an equivalent combination of education and experience (or medical device experiences can be considered)
- Quality related certifications (such as CQA, ASQ or equivalent is much preferred.
- Superior English skills are a “must have”. Prior experience with actual FDA audits, while not a necessity would be a very helpful.
- In addition, managing a cGMP factory QA team and process is essential.
- Prior experience using some form of quality management software system is critical.
We offer competitive remuneration package, 5-day work and medical insurance to the successful candidate. Interested parties, please send your Resume with expected salary.
Personal data will be used for recruitment purpose only.