Your Responsibilities : Job Description
Manage the site Compliance activities to ensure compliance of site and third party products is in compliance with the GSK Quality Standards and all relevant regulatory and legislative requirements.
Lead the development, maintenance and rolling review of the site compliance systems to support business continuity. Implement quality action plans at the site and local third parties to minimize business risks.
En-sure that Standard Operating Procedures are in place and that compliance with cGMP is maintained through internal audits.
Monitor and evaluate the level of cGMP compliance for products manufactured, packaged, tested and released at local and regional (delegated) third parties through Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs).
Continuously improve and harmonize site Compliance Systems. Strengthen quality awareness, implement the development of local third party strategic plans, support local third party contract facilities, contract operation, technical services, and process improvements.
Eliminate barriers and proactively investigate quality issues using appropriate process improvement and problem solving techniques.
Lead the preparation and management of external and corporate audits and Health Authority inspections.
Ensure that the site Compliance activities operate in a cost effective and efficient manner and maintain an innovative approach based on productivity improvement and implementation of best practice.
Management of third parties & country organisations :
Ensure adequate preparation of Health Authority inspections and audits from third parties and GCA. Lead the management of these inspections / audits and their follow-
up. Ensure that corrective and preventive actions (CAPAs) are tracked and implemented as committed and ensure timely escalation of issues related to CAPAs.
Regularly report the status of CAPAs.
Manage the site Complaints Handling processes and ensure that all product quality complaints are adequately investigated, reported and any follow-
up activities initiated in compliance with the GSK Quality Manual and regulatory and legislative requirements.
Ensure adequate trending of product quality complaints to initiate proper product improvement activities. Support the regular product reviews with product quality complaints information.
Ensure timely and complete product quality investigations related to Product Recall, Counterfeit and / or Withdrawals in close interaction with region, global and country QA functions
Define and implement all site Quality Risk Management Activities
Lead the Site Quality Review Board and all associated reporting activities
Lead and manage the site and vendor audit program. Ensure that GMP audits of third party manufacturers / licensees / key suppliers are performed as per the CH annual audit schedule and conduct due diligence audits if required.
Actively manage the Compliance team and set up their development and objective targets
Actively utilize and ensure adherence to all TrackWise workflows to manage change requests, deviations and CAPA for the site, nominated third parties and country organisations.
Actively manage third party documentation e.g. audit reports & action plans & ensure up to date on an on-going basis.
Provide leadership directives and support on quality issues
Utilize active thinking to generate creative solutions to complex technical problems
Comply and ensure compliance to Health, Safety and Environment policies, guidelines and requirements as applicable by law and GSK Corporate Guide-lines.
Comply and ensure compliance to GMP (Good Manufacturing Practices), Quality and other related policies, guidelines and requirements as applicable by law and GSK Corporate Guidelines.
Basic qualifications :
Graduate in Chemistry, Pharmacy, Microbiology or related science
Preferred qualifications :
Experience : 7- 9 years
Number of associates : 5-8
Experience in managing teams and cross functional stakeholders
Compliance & Regulatory Expertise
Quality Management expertise
Should be able to motivate team, drive results and have a continuous improvement mindset.
Why GSK? :