Beschreibung
Global pharmaceutical company based in in West London is looking for a Quality Assurance Manager to join a growing team to take on quality projects related to GDP and quality systems compliance.This opportunity offers further training and status as a Responsible Person.
Responsibilities:
Ensure that Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with US, EMA, other global and local GDP, GXP and PV guidelines.
Provide internal auditing resource to assess cluster compliance on a regular basis
Manage the review and implementation of Quality Improvement/remediation plans for the Affiliate identified through Corporate as well as internal GDP/GXP/PV audits.
Monitor GDP, GXP and Pharmacovigilance compliance to regulations and procedures and communicate CAPAs and action plans to Country Management and Corporate Quality
Act as Quality liaison between the local operational groups and Corporate Quality for GDP/GXP/PV functions and activities.
May act as a deputy for a Responsible Person (RP) and ensure that the provisions of the licence are observed in accordance with the EU Guidelines on Good Distribution Practice of Medical Product for Human Use (2013/C 343/01),
Ensure a quality management system is implemented and maintained;
Requirements:
- 5+ years of hands-on Quality Assurance / Compliance and management experience in pharmaceutical/ biotech industry.
- Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
- Good knowledge of government regulations and guidelines (local, EMA, FDA, PMDA) pertaining to GXP and Pharmacovigilance required
- Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.
- Exceptional communication and interpersonal skills
- Ability to work globally in a matrix environment
- Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
- Ability to freely travel up to 30%, (domestic and international)
Please contact Beata Klecz on for more information
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.