QA Manager

QA Manager

West Sussex

£85,000-£100,000 + benefits:

• 25 days annual leave (in addition to public bank holidays)
• Hybrid working 2 days in office, 3 from home.
• 10% bonus
• Private Medical Insurance
• Life Insurance
• Enhanced Employer Pension contribution of 5%
• Onsite parking

Key Duties and Responsibilities

• To manage the QA team and communications with Contract Manufacturing Organisations (CMOs)
• To write, review and/or maintain all TP-UK EU-GMP and EU-GDP SOPs
• To keep abreast of the regulations of the Medicines and Healthcare Regulatory Agency (MHRA) and additional European regulatory legislation and guidelines
• To ensure the company's manufacturer (MIA), wholesale dealer (WDL) and Controlled Drugs (CDL) licenses are maintained to allow importation and distribution of all company's products and all vendors and customers are compliant with GMP, GDP, MHRA guidelines
• Act as Qualified Person (QP/RP) to release batches
• To mentor, train and develop the Quality Assurance team
• To agree department budgets and ensure spend is within agreed limits
• To scope and make recommendations to management for potential vendors for new product opportunities
• To identify and report key milestone status in all new product launches
• To assist NPI team for launch of new products
• To visit Contract Manufacturing Organisations (CMOs) based on an agreed plan and for issues resolution and recommend ways to make the process efficient
• To communicate with key partners (internal and external) to ensure agreed milestones / objectives are achieved
• To continuously assess and report the resources allocated to a project to realign priorities and expectations if they change significantly during the life of the project launch process
• To reduce Cost of goods by recommending and discussing options with CMOs including alternate sources of API
• To comply with the office policies and guidelines

Knowledge & Experience

• Minimum of 5 years experience as QP
• Minimum of 3 years experience in generic pharmaceutical industry
• Understanding of European regulatory guidelines, regulations and procedures
• Experience in manufacturing and technology transfer of oral solids to CMOs
• Knowledge of GMP and GDP
• Knowledge of Regulatory Affairs, particularly MHRA
• Experience of managing a multi-cultural team
• Understanding of the timescales of the approval processes within the MHRA
• Qualified Person for release of TPUK products from listed countries (i.e. EU) & release of TPUK products from non-listed countries (i.e. outside EU)
• Understanding of pharmacovigilance practices and procedures
• Understanding of the drug development and manufacturing process

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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