Tjarda Westra
Voorhout,ZH
Summary
Pharmaceutical professional with more then 20 years experience in Quality Assurance, Life Cycle Management and Training and Quality Compliance.
Team-player who loves to collaborate with different stakeholders. Highly organized and self-motivated professional experienced in project management, team development and process improvement. Skilled in developing and implementing strategies to increase efficiency and performance. Passionate about driving business growth and creating positive work environment.
Overview
30
30
years of professional experience
Work History
Associate Director Training & Quality Compliance
SCM EMEA Hub, MSD Haarlem
2020.02 - Current
- Ensure continuous Inspection readiness (PAIR) within the Supply Chain Hub
- Manage daily operation of the Compliance team
- Ensure that all SCM EMEA Hub personnel have the correct training assigned
- Design new way of training
- Team member of the Quality Council.
Operational Manager Quality (Analytical Lab, Q Release, Q Control Support)
MSD B.V., Haarlem
2018.11 - 2020.01
- Manage, develop and motivate team (17 fte)
- Manage daily operations of the department
- Introduce, lead and support improvement projects
- Organize and participate in WTA and GEMBA rounds (EH&S)
- Support and assist in Audits (preparations) performed at MMD Haarlem
- Define CAPA's in response to Quality Notifications
- Set up training for the team as a result of GMP mistakes
- SOP reviews and approvals in MIDAS.
Operational Manager New Product Planning
MSD B.V., Haarlem
2016.06 - 2018.10
- Launch and Change management. Close collaboration is needed with internal departments such as Planning, Packaging Engineering and with external parties such as Regulatory Affairs and Marketing&Sales Department of the respective country.
- Responsible for the Technical Transfers from R&D site. This has to be translated into Project intake, control and implementation, achieve cross-functional alignment and effective communication. Manufacturing, logistical, quality and regulatory aspects should all be taken into account as well as a sound knowledge of pharmaceutical products, regulatory requirements, business processes and customers to achieve the transfer in successful manner.
- Project Management continuous improvement (label changes, supplier changes, e-leaflet)
Operational Manager Commercialized Products
Apotex, Leiden
2015.10 - 2016.05
- New Product Launch (NPL) department, Artwork department and Masterdata department (7 fte).
New Product Launch Coordinator
Apotex, Leiden
2013.10 - 2015.09
Supply Chain / Demand Management Officer
Actavis, Zoetermeer
2012.11 - 2013.05
Expat Middle East
2006.06 - 2012.08
New Product Planner
MSD B.V., Haarlem
2000.01 - 2006.01
Customer Complaint Officer
MSD B.V., Haarlem
1997.01 - 1999.01
Quality Engineer
MSD B.V., Haarlem
1994.01 - 1996.01
Education
Master of Science - Foodtechnology
Wageningen University & Research
Wageningen, Netherlands08.1993
Skills
- Project Management
- Continuous Improvement
- Ability to communicate well verbally and in writing
- Excellent organizational and planning skills
- Eye for detail
- Pressure and stress resistant
- Natural leader who demonstrates diplomacy where necessary
- Reporting and Documentation
- Onboarding and training
Languages
Dutch
Fluent
English
Fluent
French
Basic working knowledge
German
Basic working knowledge
Job Specific Skills
- People Management
- Project Management
- GMP training
- Auditing
- Change Management
- Compliance and Quality Assurance
- Lifecycle Product Management
- Supply Chain Management
Timeline
Associate Director Training & Quality Compliance
SCM EMEA Hub, MSD Haarlem
2020.02 - Current
Operational Manager Quality (Analytical Lab, Q Release, Q Control Support)
MSD B.V., Haarlem
2018.11 - 2020.01
Operational Manager New Product Planning
MSD B.V., Haarlem
2016.06 - 2018.10
Operational Manager Commercialized Products
Apotex, Leiden
2015.10 - 2016.05
New Product Launch Coordinator
Apotex, Leiden
2013.10 - 2015.09
Supply Chain / Demand Management Officer
Actavis, Zoetermeer
2012.11 - 2013.05
Expat Middle East
2006.06 - 2012.08
New Product Planner
MSD B.V., Haarlem
2000.01 - 2006.01
Customer Complaint Officer
MSD B.V., Haarlem
1997.01 - 1999.01
Quality Engineer
MSD B.V., Haarlem
1994.01 - 1996.01
Master of Science - Foodtechnology
Wageningen University & Research