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External QA Compliance Leader - Taicang

 

Job Title:                     External QA Compliance Leader                                                     Date:            August 2011

Reports To (Title):        QA Manager Shangma                                                                    Job Holder :     

Functional:                                                                                                                            Location :          Shangma, China

Division:                      Personal Care               

 

Job Purpose

  • To evaluate , monitor and control the ability of external suppliers to provide compliant and high quality products, materials or services to Reckitt Benckiser  which meet all applicable specifications and standards

Knowledge and Skills required

  • Experienced QA auditor with pharmaceutical  / medical device background.
  • Degree in science based subject
  • Trained, qualified ( lead ) auditor to ISO9001:2000 and ideally ISO13485 plus pharmaceutical GMP standards.
  • Experience of leading audits of external suppliers.
  • Excellent verbal & written communication skills
  • Fluent in English​​​​​​​

Principle Job Accountabilities

  1. To manage ( develop, document and deliver ) the audit schedule for personal care co-packers and raw  material and packaging material suppliers used by the Shangma site , plus agreed  personal care  / Healthcare co-packers within China or nearby countries  as agreed with Shangma site quality manager.
  2. To prepare audit schedules based on risk and evaluate new suppliers by means of desktop and physical audit as necessary to establish technical ability to supply to the agreed RB Quality standards.
  3. To create and maintain technical agreements with suppliers
  4. To work closely with procurement and to input into evaluation of supplier performance via agreed KPIs and report to senior management where standards are not met and propose necessary action
  5. To handle non conformances reported by RB internal or external customers and work with suppliers to ensure investigation to find root cause and take effective corrective and preventive actions. and to monitor the effectiveness of actions
  6. To monitor complaints and to work with supplier to take effective corrective action as applicable
  7. To support validation of new products at suppliers, ensuring that this is fully documented and confirms process capability.
  8. To create technical files for each supplier, referencing all applicable specifications, validations, agreements and correspondence
  9. To issue specifications to suppliers including any updates to ensure that they are always working to the current approved RB standards and specifications as agreed.
  10. To input into and work to harmonised RB quality guidelines for quality management of co-packers ( the position has a dotted reporting line into the UK External manufacturing Quality Manager


Job Segment: Medical, Medical Device, Healthcare

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