Regional Audit and Compliance Manager

  • Location

    Singapore

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    S$200000.00 - S$240000.00 per annum + bonus + benefits

  • Contact:

    Jochen Surrey

  • Contact email:

    Jochen.surrey@voltasia.com.sg

  • Job ref:

    BBBH7244_1568692970

  • Published:

    over 4 years ago

  • Expiry date:

    2019-10-17

To act as an independent assurer of quality and compliance throughout the regional operatins, including ensuring 100% compliance with Regulatory requirements and minimum company standards, reviewing and maintaining sites' compliance with ISO, ICH, EMA, FDA, MHRA, MCC and ANVISA standards as applicable.

 

The role will be part of the Compliance team and part of the broader global team. This role will lead quality assurance audits, inspections (internal and external) and monitor procedures against Standard Operation Procedures (SOPS), methods, protocols and relevant regulations/ guidelines. As such this role will have visibility and access to the highest levels of the organisation.

Responsiblities

  • Conduct audits of Manufacturing, R&D, Distribution Centres and Commercial sites within their region to ensure consistent compliance against minimum quality and compliance standards and applicable regulatory requirements.

  • Generate detailed audit reports specifying identified gap, areas for improvement and recommendations.

  • To work with Regional Quality and Compliance (Q&C) Managers to ensure all actions are fully closed out in line with expectations

  • Plan an audit schedule that ensures 100% compliance with minimum quality and compliance standards on a risk-based approach

  • Support audits outside of region but with area of expertise

  • Maintaining awareness of regulatory and Corporate related developments for quality and compliance which may impact compliance

  • Coordinate planning activities with other compliance functions (e.g. Internal Audit) to maximise efficiency and effectiveness of group audit programmes

  • Develop and maintain detailed action plans and dashboards for each site to ensure that they achieve 100% compliance against all minimum requirements

 

KNOWLEDGE AND EXPERIENCE (Knowledge and experience needed for satisfactory performance of the job).

  • Hold a Degree in Pharmacy, Chemistry or other scientific related field
  • 8-10 years' experience working with drug, medical device, cosmetics compliance in Pharmaceutical and/ or Consumer Health Industry.
  • Experience specifically experience in quality systems, regulatory affairs or regulatory compliance preferred
  • 3 years' experience conducting quality and compliance audits
  • Good understanding of Quality and compliance regulations related to a manufacturing R&D, Distribution Centres and Commercial sites site in one or more countries.

Please send your resume in WORD format by clicking the apply button below or contact Jochen Surrey on +65 6701 1516 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878834 (Jochen Nico Surrey).

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