Process Specialist
Ceredigion
£30,605 to £33,337 p/a + bonuses -quarterly – up to 10% , private healthcare etc.
Working hours…
M – F 9am – 5pm
ROLE OVERVIEW:
Accountable for providing technical expertise to the Production team. Responsible for providing appropriate training to the manufacturing team to ensure level of process and product understanding is contained.
KEY DUTIES:
- Deliver technical input into validation activities for the Production team – write, review, approve and execute studies as required.
- To perform administrative tasks and provide rapid issue resolution for all electronic manufacturing systems
- Work alongside internal & external functions to transfer new equipment and techniques efficiently to production scale.
- To foster and encourage Continuous Improvement within the Production department.
- Lead process improvement initiatives and activities to influence change.
- Actively maintain and update knowledge and expertise of current developments, standards and operating practices within the biotechnology and pharmaceutical industries
- Input into the Regulatory strategy and author the relevant sections of Regulatory dossiers to support both Changes & Deviations.
- Ensure practical training modules are in place so that new starters within the teams are provided with sufficient background understanding and knowledge before entering into their roles. Responsible for the provision of training to new starters and for robust re-training modules to maintain a high compliance within the teams.
- Provide subject matter expert input to Regulatory, internal and external audits.
- Cover operator absence within the facility as required.
WHAT YOU WILL NEED…
- Educated to degree level in an appropriate scientific discipline.
- Significant experience in a biopharmaceutical or closely related industry.
- Excellent understanding of cGMP legislation
- Computer literate
BENEFITS..
- Excellent staff benefits including private healthcare
- Fantastic holiday allowance
- Salary reviewed every quarter
- Beautiful location – countryside and coast!
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