We have an exciting opportunity for a Senior Specialist, Quality Assurance to support the implementation and execution of the Enterprise Quality System and task related to maintenance and improvement.
In addition, this role will support the Responsible person, RP and act as deputy if needed.
* 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/ self-inspection resource to assess country compliance on a regular basis
* Ensure that the company is informed about new legislation and kept fully informed of new or emerging GxP and regulatory changes in the region.
* Manage the review and implementation of Quality Improvement/remediation plans for the Affiliate identified through Enterprise as well as internal GDP/GXP/PV audits.
* Monitor GDP, GXP and Pharmacovigilance compliance to regulations and the company’s procedures and communicate CAPAs and action plans to Country Management and Corporate Quality
* Act as one of the Quality liaisons between the local operational groups and Enterprise Quality for GDP/GXP/PV functions and activities.
* Act as delegate (backup) for the 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), as follows:
* Ensuring that a quality management system is implemented and maintained.
* Prior experience and hands-on Quality Assurance / Compliance experience in pharmaceutical/ biotech industry.
* Sufficient GDP experience to act as backup (delegate) for the Responsible Person
* Thorough knowledge of applicable local and global regulatory requirements required for GDP, GXP compliance.
* Good knowledge of government regulations, laws, and guidelines (local MHRA regulations, EMA) 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 influence management, peers and other colleagues without direct reporting lines
The position is currently home based and in the future home/office based flexibility is offered.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.