Senior Quality Assurance Specialist

1 day ago

Swindon, United Kingdom Thermo Fisher Scientific Full time

**About our site**:
Our Swindon site is focused on providing both Contract Manufacturing (CMO) and more specific Condo style solutions to our clients and works on sterile drug product development. The site is going through some exciting expansion plans with lots of opportunities on offer. Right now, we are looking for a Senior Quality Assurance Specialist or QAO to join a newly developed team.

**Responsibilities**:

- Provide QA oversight to operational activities taking place within the aligned cell.
- Review of sterilization cycles, FMS systems and other key controls of clean rooms.
- Review of logbooks & support area controls.
- Online review of batch records.
- Closure of batch records with associates LIMS & SAP transactions & C of A generation.
- Review and update of Standard Operating Procedures and Controlled Documents as required.
- Supervision of clean rooms and support areas; comportment & compliance to SOPs - including actual entry into the clean rooms and maintenance of a minimum of a L1 license.
- Supervision of packaging areas; comportment & compliance to SOPs.
- Proactive generation and timely investigation/review of minor DRs & CAPA in conjunction with other cell members
- Proactive generation and timely review/implementation of level 0 & level 1 change controls in conjunction with other cell members.
- Local area & local system audits.
- Training/coaching of Operations staff & QA peers.
- Communicate effectively with other employees and participate with them in planning and problem solving activities, as required.
- Provide effective re-validation resources to the aligned cell.
- Media fill observation, incubation, reading & report writing.
- Clean room full physical - velocities, air patterns, DOP tests & particle counting.
- Autoclave load pattern re-qualification.
- De-pyrogenation tunnel requalification.
- Sterilizing filter testing.
- Cleaning Validation.
- Support clean room openings and month end client service targets by the provision of appropriate cover - e.g. weekends.
- Front line QA for regulatory audits related to the Condo and Commercial areas of the site.

**EH&S**:

- Understand emergency procedures and comply with safe systems of work.
- Ensure compliance with environment, health and safety and security policies and procedures, rules, signage and instructions at all times
- Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules

**Minimum Requirements/Qualifications**:

- Substantial experience working within a pharmaceutical quality function, preferably “steriles”.
- Significant experience working within equipment/facility validation preferably “steriles”.
- Working knowledge of the principles and guidelines for GMP as set out in the ‘Orange Guide.’
- Relevant science based degree; e.g. Chemistry, Biology, Pharmacy preferred.
- Excellent interpersonal skills with the ability to appropriately challenge others behaviours.
- Excellent report writing skills.
- Good time management.
- Proactive approach to project work with a willingness to do what needs to be done to deliver the project milestones.
- Pragmatic / common sense approach to quality incidents.
- Proven experience to problem solving - essential.
- Demonstrable ability to make sound risk based decisions.
- Ability to perform internal audits.

**Benefits we offer**:
Joining a newly created team at the site will provide you lots of opportunity for **career development**, **training** and further **opportunities** as the site continues to expand.

In addition to this, you will receive a **competitive salary** (depending on your experience), **bonus scheme**, **contributory pension plan**, **25 days holiday** + Bank Holidays, **holiday purchase scheme**, **private medical**, **life assurance** as well as the option to tailor benefits to suit you

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