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Vacancy for Regional Audits Compliance Manager at RB Healthcare

 

Clinical courses

 

Clinical courses

RB is the world's leading consumer health and hygiene company. Every day, across 60 countries, we work with the best people to challenge conventional thinking and strive to find even better ways to give people innovative solutions for healthier lives and happier homes. We trust people in what they do and we give full accountability and autonomy to make things happen. That’s how we generate the game-changing ideas that built 19 iconic Powerbrands around the world, such as Mucinex, Lysol, MegaRed, Finish and Airwick.

Post : Regional Audits Compliance Manager

JOB PURPOSE
To act as an independent assurer of quality and compliance throughout RB operations (in the applicable region), including ensuring 100% compliance with Regulatory requirements and minimum RB  standards, reviewing and maintaining sites’ compliance with ISO, ICH,  EMA, FDA and ANVISA  standards as applicable. Provide coaching and mentoring to enhance organizational compliance and defining and adoption of best practices.

KEY ROLES

  1. Conduct audits of Manufacturing, R&D, Distribution Centres and Commercial sites within their region to ensure consistent compliance against RB minimum quality and compliance standards and applicable regulatory requirements.
  2. Generate detailed audit reports specifying identified gap, areas for improvement and recommendations.
  3.  To conduct follow up visits, as required, to sites identified as High Risk
  4. To work with Regional Quality and Compliance (Q&C) Managers to ensure all actions are fully closed out in line with expectations
  5. Provide coaching and mentoring to enhance organizational compliance
  6. Define and deploy best practices
  7. To escalate issues / concerns to Regional Directors, SVPs, GQLT and the GSLT

 

PRINCIPAL ACCOUNTABILITIES
Planning

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

Training and Education
Coach Supervisors and Q&C team on requirements of Minimum standards during audit approach to help achieve consistent standards across all sites

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PERSONAL ATTRIBUTES

  1. MUST be willing to stop operations if serious quality and compliance risk identified
  2. Experience in working with Senior Management
  3. Be confident to support all decisions they make and robustly deal with challenge from all levels of the business.
  4. Be persistent and undeterred on encountering obstacles and tracking work through to completion.
  5. Have clear and concise communications skills, both written and verbal, requiring a good level of English language, with the ability to adapt communications to various audiences
  6. Be highly organised, in terms of both personal approach and reporting, to ensure all actions are suitable, practical, compliant and achievable
  7. Be self-motivated, proactive and self-sufficient and comfortable working independently
  8. Have and express a positive attitude to quality and compliance in all activities while auditing and not accept any poor practices or behaviours.
  9. Ability to build and maintain knowledge across RB.
  10. Excellent attention to detail but can also put thinking into perspective (see the bigger picture).
  11. Be willing to travel up to 70%

KNOWLEDGE AND EXPERIENCE
Holds Diploma in Biology, Chemistry or other scientific related field
5-10 years’ experience working with drug, medical device, cosmetics, reach 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.
Experience working with one or more of the following regulatory Agencies FDA, EPA, MHRA, ANVISA, CFDA, EMA etc
Experience in coaching, development and management of teams
Demonstrated ability to work across functions, businesses and internationally

Additional Information:
Industry Type: Pharma/ Biotech/Clinical Research
Location: Gurgaon
Functional Area: Regional Audits

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