Quality Assurance Manager

Neath, Wales, United Kingdom

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Pharmaceuticals, Medical ProductsIndustries

Requirements

Candidates should possess a minimum of 5 years of experience in quality management within the pharmaceutical industry, or hold a Bachelor’s degree in Pharmacy, Chemistry, Biology, or Engineering. They should have a proven track record in managing pharmaceutical Quality systems and leading continuous improvement activities. Strong knowledge of MHRA regulatory requirements and quality standards applicable to the pharmaceutical industry is essential, along with project management skills and excellent problem-solving abilities.

Responsibilities

The Quality Assurance Manager will develop, implement, and maintain the Pharmaceutical Quality System (PQS) in accordance with ISO 9001, ICH Q10, and other relevant regulatory requirements. They will ensure compliance with UK Human Medicines Regulation 2012 and the Orange Guide, oversee the development and implementation of SOPs and work instructions, prepare for and manage external audits, manage quality risk assessments, lead cross-functional teams, conduct internal audits and customer audits, provide technical guidance, support inspection readiness activities, develop and implement quality management systems, conduct regular self-inspections, lead investigations into quality issues, support customer audits, and undertake additional tasks to support evolving team and organizational needs. They will also drive continuous improvement initiatives, analyse quality data, foster a culture of quality, and collaborate with stakeholders to ensure MHRA quality standards are met.