QA Specialist (Validation)

QA SPECIALIST - VALIDATION

GLOUCESTER

PHARMACEUTICAL INDUSTRY

6 MONTHS

My client, a market leader within the Healthcare Industry has an urgent requirement for a contract QA specialist with strong Validation experience in Gloucester.

Working closely with the QA team and the decommissioning team The QA Specialist is responsible for providing quality assurance/regulatory guidance to the business with regard to their area of responsibility and specialization eg Computer System Validation, Validation, Change Control Management etc.

SKILLS/EXPERIENCE REQUIRED

Essential:

- B.S. Degree in business or technical field or equivalent relative experience to area of specialization.
- Experience in a medical device or pharmaceutical industry.
- Experience with Validation systems.
- Experience applying regulations (including FDA, cGxP).
- Proficient with relevant MS Office applications.
- Ability to identify root cause of problem and creatively problem solve to gain resolution.
- Ability to communicate effectively in English (both written and oral).
- Ability to work independently in fast-paced environment with little supervision.
- Ability to adapt to constant change and influence positive change effectively.
- Team-oriented and responsive to customer needs.
- Quality-Focused, Attentive to Detail and Results-Oriented.

Desirable:

- Knowledge of Quality Systems policies and regulations (ISO, GxP, FDA, and other key regulatory bodies) and background in pharmaceutical Quality Assurance and Validation.
- Analytical/problem solving/root-cause analysis skills.
- Familiar with Continuous Improvement methodologies, including Six Sigma.

NOTE:

You will be required to undergo a CRB check prior to commencing onsite of your application is successful.