OQ Manager

Location: Dudley, Northumberland, UKDepartment: QualityReference: VN061
Vacancy Name: OQ Manager

Summary of OQ Manager

We are seeking a suitably qualified OQ Manager for a 12 month secondment within the Quality department based in Dudley, Northumberland, UK. The successful candidate will be required to perform batch sentencing activities and all Quality Assurance activities including reviews, approvals and audits to maintain Quality standards in accordance with current Good Manufacturing Practice. Please note this is an internal vacancy.

Responsibilities
  • 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).
  • Comply with all safety, health, and environmental requirements.
  • Embody our company values, which are: be reliable, be caring, be transparent and be willing

Key Skills and Competencies
  • Applicants will ideally be educated to degree or equivalent standard in a science discipline, with experience of quality compliance management, preferably in a primary regulated cGMP API manufacturing environment.
  • Extensive knowledge of cGMP, ICH, MHRA and other regulatory requirements is essential. 
  • Good problem solving, lateral thinking and written/verbal communication skills together with an ability to operate effectively within a multidisciplinary team, are all essential competencies for this post
  • We also require candidates to be competent with IT systems, and in particular Microsoft Office including Outlook, PowerPoint, Word and Excel

You will receive

A competitive salary, pension scheme, Healthcare, Perkbox, cycle to work, 25 days annual leave, death in service coverage, on-site health and wellbeing support and medical consultation and physiotherapy, 24/7 employee assistance programme. Training and opportunities for further career development.


Why consider Sterling?

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs).  This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees.  You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day. 

Sterling is an equal opportunity employer. 

 
Be caring. Be transparent. Be willing. Be reliable.
Deadline for applications: 07 Dec 2021
Service. Passion. Science.