Vacancy for Quality Compliance Manager at RB | Degree in Pharmacy
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 : IMEx Quality Compliance Manager - South Asia
To ensure that the activities carried out by the businesses in South Asia are compliant to all quality and regulatory requirements as described in the RB Business Management System (BMS-QMS), associated policies and local regulations. Participate in the local management teams as a representative of Quality.
The individual should have knowledge of the Principles and Guidelines of Good Manufacturing Practice and how the principles of GDP maintain product quality throughout the distribution chain.
SCOPE / DIMENSIONS OF ROLE:
* Provide quality and compliance support for the product portfolio in South Asia
* Ensure on-going quality compliance of RB
* Lead and co-ordinate the resolution of quality, medical and product safety issues affecting products in South Asia
* Relentless Obsession with products on shelf – lead intelligent evaluation, interpretation of data and promote actionable tasks, leading remediation drive
LOCAL QUALITY MANAGEMENT SYSTEM (QMS)
1.Responsible to support the GM’s and their management teams to enable them to develop and implement the local Quality Management System (QMS) to ensure fully compliant products.
2. Work with local functions to develop and maintain all relevant procedures in line with the requirements of the Global BMS & associated policies, relevant codes of practice and GMP/GDP and local requirements.
3.Ensure that QMS is maintained in a state of inspection readiness.
4.Ensure processes are in place to assess the adequacy and effectiveness of the local QMS.
5. Ensure that improvements to products and procedures can be identified and fixed.
6. Implement QMS for new operational models – e.g. Cross Border.
7. Lead Management Reviews – compiling overall KPIs – Key Performance Indicators
The individual should understand
8.the role of Regulatory Authorities in the licensing of Medicines/Medical Devices/Health Food/Cosmetics
9.the current regulations related to Medicines/Medical Devices/Health Food/Cosmetics in relation to storage and distribution
10.Good Supply Practice for Medicines, Health Food, and Medical Devices.
SPECIFIC INVOLVEMENT IN QMS PROCESSES
11.Change Management: Facilitate the development and maintenance of robust and effective locally-based change control system to ensure compliant Market Authorisations and launch of new products in South Asia.
12. Training: Train all staff in commercial organisation on the requirements of QMS/GDP, GSP & associated policies.
13. Product Recall – as per the Critical Quality Events and Product Recall SOP establish and communicate responsibilities. Participate in mock recall exercises to confirm adequacy of the local recall procedure.
14.Issues/ complaints management: For quality issues/ complaints originating in the commercial function, carry out investigation and apply corrective and preventive actions to prevent recurrence.
15. Internal auditing: Responsible for implementing the local audit programme covering: country businesses, 3rd parties, embellishers and other service providers under scope of responsibility.
16. Maintain a Fit-For-Purpose QMS: Report level of compliance of local QMS versus Global Policies and GDP/local requirements regularly to Regional Quality Director, GM’s, SVP’s, EVP’s and drive closure of gaps to maintain.
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