Job Purpose
To support the on-going stability program for commercial, clinical and technical products. In addition support of quality control testing of both development and market finished products under GMP conditions.
Key Responsibilities And Accountabilities
- Work as part of a team alongside quality control and micro departments
- Actively involved in performing analytical activities for stability analysis of drug products
- Must be technically competent in analytical activities (e.g. pharmacopoeail wet chemistry, HPLC, GC, Dissolution, KF) for stability testing of finished products. All activities to be performed under current cGMP, In house SOP’s and/or pharmacopoeia
- Writing of stability summaries, protocols and reports
- Performing set down of new stability studies, receipt of stability samples being returned from storage facility and disposal of samples following reporting of analysis
- Checking of data for stability, QC and micro departments
- Ordering of lab supplies to ensure continued availability of materials for timely analysis
- Comply with company health and safety procedures
Person Profile
Results oriented with a positive outlook and clear focus on high quality output: Solid planning and organizational ability; Reliable, tolerant and dependable: Comfortable dealing with senior managers and customers: Enjoy working in a fast, stimulating environment. Goal-oriented: Able to work under pressure and meet deadlines; Excellent communication/ presentation skills. Able to get on with others and be a team player, but is equally comfortable working independently.
Flexible and able to work extended hours when required.
Required
- Relevant qualification, HNC/HND/Science Degree or Equivalent
- An understanding of drug development and stability processes
- Demonstrated technical competence of the technical and practical skills involved in analytical activities to prescribed quality standards
- Must be skilled in analytical techniques eg HPLC, Dissolution, Gas Chromatography, KF and wet chemistry techniques
- Able to communicate well with others, both laboratory and non-laboratory based
- Able to work with minimal supervision.
- Good understanding of quality control, SOP and GMP adherence
Desired
- Have a broad knowledge with and experience of working within a cGMP/GLP environment.
- 2-3 years experience of working within a pharmaceutical or biotechnology industry
- Ability to work to key regulatory and compliance requirements
- Experience of quality control/Stability within a pharmaceutical environment
- Experience of Chromeleon software
- Experience of data reporting and checking data within a QC environment
- Understand and demonstrate a pragmatic approach to problem solving with GMP constraints.
Computer skills
Must be competent in the use of MS Office, particularly Excel and Word, e-mail and internet.
Literacy and Numeracy
Must be competent in writing reports both for internal use and for customers. Must be competent in the interpretation of analytical data.
Business Presentation Skills
Must be an excellent face-to-face and telephone communicator.
Equal Opportunity Statement
Only Candidates with a permanent Right to Work in the UK will be considered.
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