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Are you passionate about innovation and quality in the pharmaceutical industry? Do you thrive in a dynamic and supportive work environment? Quantum Pharmaceutical, part of the Target Healthcare Group, is looking for talented individuals to join our team and help us achieve our mission. “To become the UK’s leading provider of aseptic products by driving innovation, delivering unmatched quality and service, and building strong partnerships, setting new industry standards.” Transform Healthcare with Us! At Quantum Pharmaceutical, we’re revolutionising the delivery of aseptic medicines, and we are seeking a passionate Quality Assurance Officer to join our mission. Our Quality Assurance department is the heart of our operation, ensuring every product meets the highest standards of Good Manufacturing Practices. As we expand, we are seeking a meticulous and dedicated Quality Assurance Officer to join our elite team.
Job Responsibility:
Managing quality assurance activities such as Deviations and CAPA management, Change Management while assuring compliance with established standards, regulations, specifications, and SOPs
Ensuring that documentation follows current Good Manufacturing Practices, current Good Documentation Practices, and external regulations
Assure the safety and quality of the products, processes, and systems
Developing and maintaining procedures, and policies to assure compliance with cGMP’s
Ensuring all documents are created, distributed, stored, and archived in line with regulatory requirements
Ensuring all systems, operations, products, processes, procedures, and documentation for adequacy and effectiveness to ensure Quality and Regulatory Compliance to related CAPA
Leading, participating in, and reviewing all types of investigations, Root Cause Analysis and Quality Risk Management
Applying problem solving logically and in an organised manner
Must have experience with Root Cause Analysis tools and the ability to apply tools
Leading and assisting with both internal and external audits and audit reports
Assessing and implementing regulatory changes
Identifying any relevant quality-related training needs, provide training tools and deliver training
Requirements:
Experience of operating in a similar role is desirable
Bachelor’s degree with 2 or more years’ experience in Quality, Manufacturing, or related field
Experience working in pharmaceutical / healthcare / life sciences industry advantageous
Ability to communicate efficiently verbally and in writing with all levels of the organisation and with external clients
Detailed knowledge of applicable regulations and standards
Strong analytical/problem solving skills
Knowledge of electronic Quality Management systems (eQMS) will be advantageous
Demonstrable experience of working autonomously and making decisions with minimal direction
Ability to travel to other sites and for vendor audits
English and Mathematics GCSE grades A-C (or equivalent)
High computer literacy
experience operating with all Microsoft Office software