We are recruiting for an experienced OQ Manager on a permanent basis to work in the North East of the UK for a successful pharmaceutical company. Our client is based in Cramlington, this is roughly 20 minutes north of Newcastle by car and well connected to public transport.
As an OQ Manager you’ll report to the Head of Department - however you’ll have autonomy over your daily activities and responsibilities.
What you’ll do:
- As a SAP user the job holder will be required to carry out assigned SAP transactions in an accurate and timely manner.
- Sentence all controlled intermediates and finished goods in an agreed timeframe, in accordance with written procedures. These cover production and analytical review, deviation and change assessment.
- Responsible for all OQ approvals of PRSs, changes (process, analytical and engineering procedures) which relate to specific products to ensure they are carried out in accordance with relevant product registrations.
- Perform OQ assessment of all ‘Decision Paths’, non-conformances and deviations (including out of calibration).
- Review all cGMP cleanouts and ensure manufacture is not commenced prior to completion of a satisfactory cleanout.
- Ensure that specific product set and specific plant/business areas are cGMP compliant through audit, review and monitoring. Identify relevant corrective actions and ensure they are closed out through QATs.
- Maintain OQ systems covering change control
- Approval of master PRS’s and procedures
- Handle complaints, audit observations and customer notifications and co-ordinate annual reviews.
- Responsible for co-ordinating validation activities and Document Reviewer activities.
- Degree or equivalent in a scientific discipline.
- 5-10 years experience in Active Pharmaceutical Ingredient or Pharmaceutical Industries, in quality assurance.
- Comprehensive knowledge of all cGMP requirements/guidelines applicable to API manufacture.
- API quality assurance, laboratory practices and production.
- Auditing principles and practices with recognised certificate.
- Excellent skills in communication and the writing of SOPs and reports.
To apply for the OQ Manager role:
Cover notes supporting your application are welcomed. On this occasion LiCa Scientific is acting as an employment agency.
Please email firstname.lastname@example.org with your most up to date CV and a cover letter.