Dr. Ali Gul (Pharm D, Rph, MBA)

Experience

• 

  Abbott

  Aug 2003 - May 2004

  Production Officer
• 

  Novartis Pakistan

  Aug 2004 - Jun 2012

  Senior IPC Monitor
• 

  Novartis Pakistan

  Aug 2012 - May 2016

  Implementation of Novartis Quality standards and GMP requirements within assigned third party sites to provide direction and support for all quality matters. Process improvements by identifying and controlling process variables. Performed RCA to handle deviations & customer complaints, made appropriate action plans with the help of cross functional teams to avoid recurrence of the same GMP issues.

  • Quality Assurance Manager (TPOs) Tech Ops OTC.

    May 2015 - May 2016

  • Assistant Manager IPC (Quality Operations)

    Aug 2012 - Apr 2015
• 

  GSK

  Jun 2016 - Jul 2023

  • Manage Quality Assurance (QA) activities within the Operating Unit (OU) to ensure compliance throughout their Product Lifecycle with corporate guidelines and all relevant regulatory and legislative requirements.• Direct reporters include Assistant Manager QA Operations, QA Product Release Lead, QA Operations representatives at Jamshoro, Key operations include Batch Release, Change Control Implementation, In process monitoring from dispensing to packaging, Facility GMP compliance, Handling of deviation and CAPA, Quality Investigations, Risk Management, QMS Implementation, review of manufacturing and packaging instructions and other production documents.• Lead the development, maintenance and rolling review of quality systems within the OU to support the OU business continuity. • Implement quality action plans at OU to minimize business risks.• Monitor and evaluate the level of cGMP compliance for products manufactured, packaged, tested and released at local and regional through Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs). • Continuously improve and harmonize the OU Quality Systems, strengthen quality awareness, support process improvements, product quality review, eliminate barriers and proactively investigate quality issues using appropriate process improvement and problem solving techniques.• Ensure that all new product launches are in line with Global Corporate GMP requirements and actively provide strategic direction to support the OU business targets in close collaboration with regional QA team.• Evaluate, investigate, track and complete complaints through effective and established complaint handling process additionally evaluate reported issues received through multiple customer feedback channels to identify alleged deficiencies.• Implementation of Quality Systems: Translation of Global Quality Directives & Standards into the site SOPs in accordance to local regulatory requirements, and implementation through training. Show less Worked as QA Product Release Lead at GSK Consumer Healthcare reporting to Head of Quality Assurance, responsible for all activities of QA Operations. Direct repartees include Assistant Manager QA Operations, QA Operations representatives, Key operations include Batch Release, Change Control Implementation, In process monitoring from dispensing to Packaging, Facility GMP compliance, Handling of deviation and CAPA, Quality Investigations, Risk Management,review of manufacturing and packaging instructions and other production documents. Show less

  • Operational Quality Lead

    May 2016 - Jul 2023

  • QA Product Release Lead.

    Jun 2016 - Dec 2016
• 

  SJ&G Pharmaceutical Group

  Jun 2023 - Mar 2024

  Quality Assurance & Compliance Manager
• 

  Medical Devices Industry

  Apr 2024 - now

  Site Quality Head