Beschreibung
Quality Assurance Specialist - GDP - 6 Months contractGlobal pharmaceutical company based in Middlesex is looking for a quality assurance consultant for initilat 6 months contract for 3 days per week.
The role will be focused on supporting implementation of quality systems and supporting the Responsible person in daily tasks.
Daily tasks:
Partner and collaborate with leads and colleagues to ensure the roll out and on-going compliance to the global quality and compliance systems, and associated procedures and standards to the responsible cluster.
Provide leadership and resource management support to Corporate Quality and the designated Affiliate
Ensure that the company's 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
Ensure the compliance with 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 Corporate as well as internal GDP/GXP/PV audits.
Provide Quality Expertise and leadership to the designated Affiliate and lead local/regional Quality activities
In collaboration with the Corporate Quality organization, weigh and communicate quality and compliance risks as appropriate
Act as Quality liaison between the local operational groups and Corporate Quality for GDP/GXP/PV functions and activities.
Partner with local, regional and global operational groups to foster a proactive approach to compliance.
Requirements:
Already gained experience in Quality Assurance / Compliance and management experience in pharmaceutical/ biotech industry.
Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
Strong leadership ability.
Good knowledge of government regulations and guidelines ( local, EMA, FDA, PMDA) pertaining to GXP and Pharmacovigilance required
Strong knowledge of pharmacovigilance AE reporting systems and regulations 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
Please call Beata Klecz on or send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.