Senior Stability Analyst
- Experience Level
- Experienced (non-manager)
Truly global Pharmaceutical Company seeks an experienced Senior Stability Analyst.
About the role:
Undertake analytical testing, verification, associated laboratory duties and assist the Laboratory Manager in ensuring safety and satisfactory quality standards in the materials manufactured.
Duties may include:
- Test stability samples while meeting deadlines and following an assigned schedule according to standard testing hours.
- Ensures that the production schedules are met.
- Liaises with production management, quality, planning and technical to ensure that the needs of customers are identified and satisfied and business goals are met, this includes work allocation and monitoring of team activities.
- Proactively addresses team's performance.
- Instigates and documents OOS results and prepares reports.
- Ensures that pharmaceutical products are stored properly
- Liaises with other professionals regarding the development, manufacturing and testing of pharmaceutical products.
- Prepare analytical reagents/media/cultures for general laboratory use.
- Ensure that any waste materials are processed, recorded and disposed in accordance with cGLP, safety and environmental requirements.
- Ensure all activities are performed in compliance with customer and ICH procedures.
- Ensure that all instruments are calibrated and adequately maintained prior to use.
- Generates stability reports suitable for inclusion in regulatory dossiers.
- Undertake non-routine analysis and assist in the introduction of new products into the laboratory when required.
- Maintain appropriate records of analytical results and report any anomalies or out of specification results to the laboratory management.
- Assist in the training of new personnel when required.
- Undertake tasks necessary for the efficient operation of the laboratories.
- Understand product requirements and processes to participate in product specific cross functional teams.
- Stability Diary
Skills and experience:
- Degree in Chemistry / Micro / Science and 6 + years' experience in a similar role.
- HNC/HND and 6 years + experience in a similar role.
- Stability Reports
- Stability sampling programme
- New product introductions
- PCN requirements