Johnson & Johnson Careers
[Medical Devices] Associate QA Manager
Requisition ID: 1905763572W
Overall purpose of job:
The position is designed to ensure the implementation of Quality System Compliance within the scope of
CLS activities in HK/TW and supporting as well Regional CLS Q&C Strategies on the quality and compliance execution, through:
- Implementing and evaluating a highly effective Quality & Compliance Function and Awareness within CLS NORTH ASIA Community – cross sectors
- Independently partnering with TW/HK business quality, Regional CLS, JNJ supplier quality and operational leader as well as other affiliate for Q&C CLS
- Close collaboration with business quality, local regulatory team, Supply Chain, and JNJ TPL
Essential duties and responsibilities:
- Ensuring TW/HK DC under scope of CLS meets all appropriate related requirement such as: regulatory authority, and sector requirements.
- Support and maintain regional Q&C CLS Dashboard as per agreed target
- Implement and support Quality System implementation within the scope of CLS, includes ensuring TW/HK sites meet CLS DC QSCAN, GWP requirements and conducting internal audit to JNJ TPL as well as ensure satisfactory closure of JJRC AAP of JNJ TPL.
- Support CIP program related to CLS Q&C at TW/HK.
- Ensure compliance of TW/HK sites to the Global and Regional Guidelines and Policies including enterprise standards related to Quality and Regulatory Compliance for CLS.
- Established quality agreement at all TW/HK JNJ TPL for warehousing, transportation and other 3rd party services related.
- Flawless execution on global standard requirement for repack/relabel facilities at TW/HK under scope of CLS.
- Ensure timely JNJ DC quality reviews are conducted and actively participate on management review of site business quality
- Support an appropriate and timely closure of related to quality and compliance customer complaint at JNJ TPL of TW/HK.
- Maintain and monitor system compliance such as for NC/CAPA, training program, change.
- Partners with CLS Operations to implement business solutions and leads compliance efforts associated with complex projects and activities through effective implementation of the Audit Action Plan (AAP) process
- Supplier Audit program and ensure inspection readiness and provide strategic focus for quality and compliance by working with appropriate functional areas to identify continuous improvement opportunities
- Coordinates and reports timely and accurate metrics and analysis per J&J policies. Reporting responsibilities within TW/HK include (but are not limited to): Metric evaluation and reporting in CURVE entry updates.
- Accountable for Quality management of repacking, relabeling, over labeling, kitting, and reworking operations conducted within the DC
- Accountable for accurate and timely communication of temperature control excursions occurring within the DC to appropriate partner
- Accountable for the investigation of temperature control excursions and subsequent remediation activities
- Accountable for overseeing the controls and quality standards for all distribution
1. More than 6-year experience in QC or QA Function of any Medical devices or Pharmaceuticals Industry
2. Bachelor Degree in Science (Life Sciences, Microbiology, etc) or Engineering required.
3. Good knowledge of Good Distribution Practices (GDP), GMP and validation- demonstrated knowledge and application of QSR, ISO9001, ISO13485 and other international standards.
4. Certified Auditor of GMP, ISO 9001, or ISO 13845.
5. Knowledge of manufacturing environment or repackaging/relabeling environment
6. Fluency in English language required.
Johnson & Johnson Medical Taiwan Ltd. (8582)