Quality Assurance Specialist - Medical Devices, Pharma, Medicinal
Currently remote based
Maternity cover until November 2021
Rate: Competitive Hours: Monday - Friday 37.5 hours p/w
Here at SRG we have a fantastic new opportunity for an experienced QA Associate to join a Global giant in the medical device and pharmaceutical industry. You would be working alongside experts in the field of Quality, providing support to a team that sees a variety of medicinal and medical device products that support the lives of millions.
You would be supporting the development and ongoing management and improvement of formally documented supply chain processes for each medical device product.
The requirements of the role are as follows:
- To lead, prioritize and provide an effective Product Release Service which comply with Company GMP standards, Product Quality Specifications and Regulatory requirements.
- To generate and review product related technical documents such as Product Quality Reviews and Quality Agreements.
- Collation and interpretation of data and information such as analytical results/trends, regulatory/validation/engineering information to lead and direct investigative work into products failing to meet requisite standards (and regulatory issues).
- Also to develop and agree corrective actions arising from such incidents.
- To investigate and report product customer complaints.
- Lead deviation investigation clinics
To join the team you will need ideally:
- Experience in quality assurance and compliance, manufacturing and/or development, working with consumer and/or pharmaceutical products.
- With knowledge of GMP (and regulatory) requirements and ideally with the following skills and experience: HNC, Degree in Chemistry or equivalent in a science subject.
- Proven record of supporting of quality operations and manage multiple activities concurrently as roles are within high volume, complex areas.
- General knowledge of regulatory compliance requirements, including medical devices would be an advantage.
- Experience with QMS documentation processes required for product release, complaint management and coordination of formal agreements.
- Excellent written/oral communication skills, interpersonal relationship building and team working skills.
- Ability to demonstrate leadership would be an advantage as depending on knowledge and experience, the individual may be required to lead a small shift team
To apply please click the link or submit your CV direct to Sarah at email@example.com or call Sarah on 0161 8682249 for further information.
Key words: QA / quality / deviations / non-conformance / medic / device / CAPA / investigations / complaint / pharma / assurance / regulatory / batch / review / documentation / verification / release / compliance / change / control / adverse
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