- Collate and review pharmaceutical product batch files for timely release by Responsible Person (RP) or certification by Qualified Person (QP).
- Provide timely Quality reviews for Primary and Secondary packaging lines.
- Raise in a timely manner on request or using own initiative Third party notification, CAPA, Deviation and Change Control.
- Monitor alerts for potential overdues for Complaints, CAPA, Deviation and Change Control.
Job Responsibilities
- Assist in the Pharmaceutical Quality Management of all Waymade, Sovereign Medical, and Atnahs products.
- Assist in the generation and maintenance of procedural and controlled documentation.
- Undertake both Primary and Secondary packaging line Quality start up and in process checks.
- Report issues which may impact on product release in the first instance to Senior Quality Officer (in their absence to Qualified Person and/or Head of Quality).
- Collate and review batch paperwork for manufacturing, packing and QC testing prior to the certification/release of the product by a QP/RP.
- Generate summary reports for Stability Results.
- Generate summary reports for Annual Product Quality Review.
- Complete facilitation or assigned tasks in relation to the following Pharmaceutical Quality Systems:
- Department Risk Assessments
- Training Effectiveness Reviews
- Root Cause Analysis
- Ensure data integrity is established and maintained in accordance with the ACOLA+ guidelines.
- Responsible for helping to maintain Key Performance Indicators (KPI's)
- Other duties as assigned, at the discretion of Line Manager.
Key Accountabilities
- Demonstrate flexibility and willingness to assist and ability to work in a team environment
- To be punctual, polite and courteous
- Ability to work on own initiative
Your Experience & Skills
- Able to work flexibly and under own initiative
- Strong attention to detail
- Excellent communication, both written and oral
- Excellent working knowledge of Good Manufacturing Practice
- Time management Skills
Hours and working arrangements:
- This is a permanent role, and full time (37.5 hrs per week). Your daily hours (7.5) 08.00 - 16.00 Monday to Friday.
- Given the nature of the role, you'll be working on-site.
Next Steps
- If this sounds like the right role for you, then we welcome your application.
We endeavour to reply and feedback to all applications; however, when a popular role becomes available, it's not always possible, so if you have not heard from us within 30-days please assume that we couldn't take your application further on this occasion.
We are committed to encouraging equality, diversity and inclusion among our workforce, and eliminating unlawful discrimination. The aim is for our employees to be truly representative of all sections of society, and for each employee to feel respected and able to give their best.
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Waymade PLC, Monarch House, Miles Gray Rd, Basildon, SS14 3RW