Overview
Reference Number: JO-2307-519735
Quality Assurance Manager
Rate: Negotiable
Job Type: Contract
Location: Macclesfield
Quality Assurance Manager
Macclesfield (3 Days Onsite)
6 Months – 36.5 hours per week
Inside IR35 £42.00 (PAYE) or £52.00 (Umb)
CPL Life sciences have teamed up with a leading Pharma company looking to recruit a Quality manager on a 6 month contract. The successful candidate will be responsible for Quality Assurance activities that directly support execution of Quality Management of Suppliers responsible for the intake of Product Quality Complaints on behalf of Affiliate Quality.
Key activities include:
• Quality System oversight and/or performance of: audits, change control, product quality complaint and deviation investigations, issue management and escalation, Agreements (establishment and maintenance) between client and External Suppliers.
• The preparation and submission of Supplier Quality Assessments, Regulatory Agency interactions (prep and management of inspections at external suppliers and clients sites when external suppliers are assessed).
• Accountable for driving process the performance of the Vendor, Point of contact for Affiliate Quality and cross functional colleagues in relation to product quality complaints for applicable region.
• Works closely with Global Process Owners to ensure local and global alignment across all areas of Product Quality Complaints management.
• Completes assigned training and maintains personal training records, dedicates time to self-development and works with manager to develop a dedicated personal development plan.
• This role will be a key interface between the Business and operational vendors in order to deliver operational excellence.
Education, qualifications and skills needed
• Bachelor’s degree in science or technical area
• Considerable industry experience across a wide range of international Operations or Research and Development functions
• Proficiency in global regulatory requirements for PQC handling
• Proven experience working on critical acute problems in multifunctional, international senior-level teams
• Experience working in GMP/GDP in an above-country role and/or with vendors
• Maintains an up to date knowledge of international product quality complaint regulations.
• Verbal and written English skills are mandatory
• Experience in managing/supporting inspections
For more information regarding this role please apply within or send your CV to amy.goddard@cpl.com
