Senior QA Officer Systems

Role Details

Quality Assurance Officer – Systems Role: Full-time, permanent

Location: Barnstaple, Devon

Salary: Competitive + bonus + benefits

The Role

We’re seeking a methodical and proactive ‘Quality Assurance Officer – Systems’ to support, challenge and continually improve the optimal running and maintenance of our Pharmaceutical Quality Systems (PQS) in accordance with EU and corporate requirements; this may include documentation and training management systems, through to Quality Management Systems (QMS) for our manufactured, packed and tested products. Taking time to gain a thorough understanding of our different systems, you’ll start by supporting troubleshooting activities – be this through self-driven system investigations and diagnostics, working with local system SMEs and colleagues at our parent company, or liaising with our system suppliers to rectify any issues. Once you’re familiar with our systems, you’ll support our continuous improvement initiatives, ranging from identifying the best way to adjust systems to answer regularly reported issues to partnering with key stakeholders across the business, supporting system redesigns to enable changes to ways of working or ensuring our systems remain compliant and fit for purpose, along with improving Quality reporting measures. To support the smooth running of the QA department, you’ll ensure effective SOPs and Wis are issued and regularly reviewed and prepare / review accurate Technical Agreements for our products and suppliers. You’ll also have the opportunity to get involved with internal inspections and external customer audits, identifying Quality risks and implementing any required mitigating actions, and the delivery of relevant system and GxP training to the business to maintain our strong QA culture.

Key Responsibilities

• Oversee and maintain the Pharmaceutical Quality System (PQS), driving continuous improvement in line with EU GMP, regulatory requirements, and corporate standards

• Manage and support the investigation and closure of deviations, ensuring effective implementation and follow-up of Corrective and Preventive Actions (CAPAs) with internal stakeholders and contract manufacturers/packagers

• Lead and manage product quality complaint investigations, ensuring timely closure and appropriate escalation of quality and pharmacovigilance-related issues.

• Review, approve, and oversee Change Controls, CAPAs, quality risk assessments, and associated quality system documentation.

• Provide quality oversight of supply chains, and third-party service providers to ensure ongoing GMP compliance.

• Review and maintain Technical Agreements, Regulatory Compliance Files, product specifications, and other quality-related agreements with suppliers.

• Review and provide quality oversight of regulatory documentation, including dossiers and Module 3 submissions, ensuring compliance with registered details and regulatory commitments

• Support the preparation, review, and approval of Product Quality Reviews (PQRs)

• Liaise with regulatory authorities, customers, suppliers, and other external stakeholders on quality-related matters as required.

• Lead and contribute to quality improvement initiatives and cross-functional projects to enhance compliance, efficiency, and product quality.

The Person

• Experience of working with Pharmaceutical Quality Systems; an understanding of Quality regulations would also be beneficial.

• Experience in a previous Quality Assurance role, or significant experience of using Pharmaceutical Quality Systems, with an understanding of manufacturing processes.

• Practical experience of managing investigations or root cause analysis processes; an understanding of CAPA, change control, deviation management and audit processes would be beneficial.

• Good IT skills (including Microsoft Office), experience of working with systems to support day-to-day queries or design changes to optimise usage; able and keen to learn new systems quickly.

• Excellent communication skills (written and spoken), confident building relationships at all levels, utilising influencing and persuasion skills to manage change and navigate cultural differences.

• Good organisation skills – able to manage multiple workstreams to meet deadlines and maintain an eye for detail and methodical approach, even in a fast-paced working environment.

Flexible in approach but process-minded, with good planning and problem-solving skills along with the ability to adapt to changing business needs, as required.

The Rewards

In return, we offer a competitive salary and rewards package (including 25 days’ holiday + bank holidays, bonus scheme and a company pension scheme). Not to mention the opportunity to genuinely make a difference in a new and dynamic role within a progressive and expanding business, at an exciting time of growing international reach.

How to Apply

If you possess the experience, passion and ability to make this role a success then we would like to hear from you. Please complete your Candidate Profile on our careers site to apply for this role. The closing date is 01/06/2025. For more information, you can contact us on: careers@accord-healthcare.com

A Bit About Us

Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies selling generic medicines in over 80 countries around the world. This global footprint enables us to deliver vital, affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide. The approach of Accord is agile and inventive, always seeking to improve products and patients' access to them. Accord are driven to think differently and deliver more for the benefit of patients worldwide.

To continue our growth, we’re looking for the best and brightest technical minds and forward-thinking business professionals. Keeping our people at the heart of all we do, we offer rewarding opportunities for those looking for continued personal and professional growth, investing in training and development tailored to each individual’s focus. So, if you’re looking for an inclusive company to take your career to the next level, you’re certainly in the right place; come and join us to make it better.

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All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

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