IPT Quality Officer – Pharmaceutical
Central Employment are currently looking for an IPT Quality Officer to work with Organon (MSD Cramlington) for a minimum period of 12 months. This recruitment is open to both external and internal candidates already working at MSD. The ideal background will require a strong understanding of root cause analysis, dealing directly with customers, and great attention to detail. Familiarity with the deviation process and supporting OOS results will be highly desirable.
You will be expected to support and enhance site compliance to all regulatory and quality requirements, operating within established quality systems, according to business requirements, training & experience. Ensure data accuracy and report integrity in all areas of responsibility. Act as an advisor on Quality/Compliance matters, ensuring that all activities follow the correct processes and procedures in a maximized and efficient way in accordance with appropriate internal and external guidelines. Develop proactive relationships with key stakeholders, (internally & externally) and perform all activities in accordance with cGMP requirements. Support compliance and continuous improvement activities.
- Perform real-time document checks & reviews.
- Support IPT processes by providing quality input into documentation and compliance concerns during routine running operations.
- PMO (Paperless Manufacturing Operations) review for manufacturing and packaging and approval of manufacturing work orders.
- Perform GMP review of batch records and associated data, including review of regulatory impact tables.
- Investigations – provide quality assistance and input to manufacturing deviations and customer complaints as required.
- Formula review (template) & approval.
- Review and approve equipment change control.
- Equipment qualification documentation QA review.
- Approval of SOP’s.
- Audits and self-inspections – support.
- Improving own business processes.
Qualifications, Skills & Experience
- At least 3 years’ experience in the pharmaceutical industry or scientific experience within a commercial laboratory.
- Good written and spoken communication skills and ability to lead cross-functional teams.
- Ability to form good working relationships with other functional groups.
- Excellent understanding of cGMP requirements
- Attention to detail and well-organized approach to working.
- Degree/HNC in Chemistry, Pharmacy or other scientific statistical discipline is preferred.
- Previous experience of validation, change control, stability work is preferable.
- Required to comply with the company Policies, Procedures, and Guidelines, regulatory requirements, and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
- As the holder of this role, you are responsible for making major GMP decisions that may have a significant impact on the site and our customers, therefore you have the authority to act within this responsibility with due care and diligence.
If this role is of interest, please get in touch with George Hixon @ Central Employment
Tel: 0191 232 4816