Senior Quality Assurance Specialist

3 weeks ago


Oxford, United Kingdom Perspectum Full time

Are you a seasoned Quality Assurance specialist with a passion for ensuring the highest standards in the medical device and/or pharmaceutical sector?

Look no further Our dynamic Quality and Governance department is seeking a highly skilled and experienced Senior QA Specialist to lead and coordinate Research Governance and Quality Assurance workflows, contribute to continuous improvement and play a proactive part in Quality Assurance and Governance activities

**About the role**
- Coordinate and oversee Research Governance activities, ensuring adherence to local processes and policies.
- Lead and optimise QA workflows to guarantee the highest standards of quality throughout the product development life cycle.
- Ensure strict compliance with local regulations, company policies, and industry standards.
- Drive initiatives for continuous improvement in QA processes, fostering a culture of excellence and innovation.
- Effectively manage Corrective and Preventive Action (CAPA) processes, addressing issues promptly and implementing robust solutions.
- ️ Oversee internal and external audits, with a focus on CAPA management and timely follow-up on audit findings.
- If you possess Lead Auditor certification, you'll have the opportunity to take a leadership role in shaping our audit processes.

**About You**
- Established experience within a quality assurance role or a related field such as, healthcare, pharma/ medical device or software development that can be valuable for Quality Assurance.
- Experience as an internal audittor, including clinical trials and GCP auditting.
- In-depth understanding of local and international regulations governing the medical device/pharmaceutical industry (ISO 13485, ISO 14971, GCP guidelines) as well as understanding of software development cycle.
- Your soft skills will include: strong interpersonal and communication, time management, independent and team working, detail orientated, multi tasking, organisation and prioritising. You will also have meticulous attention to detail.

**About Perspectum**
- Contribute to groundbreaking medical innovations and advancements that impact lives globally.
- Be part of a company that operates on an international scale, shaping the future of healthcare with a commitment to quality and compliance.
- Embrace a culture of continuous improvement, where your expertise will drive enhancements in QA processes and policies.
- Work with a diverse and talented team that values collaboration, creativity, and excellence.

At Perspectum, we offer our employees a flexible, fast-paced and fun environment. We are driven by hiring the best talent, who share our values of excellence, accountability, integrity, openness and passion.

We value our employees and are constantly striving to ensure we provide a working environment that offers something for everyone, whether that be flexible working, training opportunities or health and wellbeing initiatives. Benefits include:

- 33days annual leave (inclusive of Bank Holidays), increasing with service
- Discretionary bonus scheme
- Private healthcare including medical referrals, discounts, access to counselling and nutritional support, and cashback on healthcare bills
- Life assurance
- Pension contribution rising to 6% after 2 years service
- Hybrid working - we like our employees to be in the office 3 days per week. Our sociable working environment includes office break-out/game areas as well as social events on site.
- Office Facilities include free on-site parking, refreshments, onsite showers and changing facilities, bike locks and Electric Vehicle charging points.



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