Stability Specialist - Office based role Permanent Devon Attractive salary and package
As a Stability Specialist you will be responsible for:
- To provide leadership for the stability team.
- To ensure compliance with legislation and regulatory bodies with regards routine and non-routine stability trials.
- To manage the stability study life-cycle.
- Managing multiply studies to strict deadlines ensuring that all tasks performed meet the required standards in compliance with regulations.
- Communicating to the stability team over workload allocation, priorities and expectations. Having difficult conversations with internal and external partners over challenges and performance.
- Managing a specialist team to generate stability data.
- Ensure that the stability programme is kept up to date, compliant, followed and that all data is generated to meet overall program, GMP and business needs.
- Understanding of Pharmaceutical GMP for Stability to meet ICH requirements.
To apply for this position you must have:
- Honours degree in Analytical Chemistry, Pharmaceutical Sciences or equivalent scientific experience.
- Relevant experience working within a analytical Laboratory in a Pharmaceutical Company.
- Good knowledge and understanding of Analytical Chemistry and Microbiology including stability indicating methodology and development.
- Previous experience working within the Pharmaceutical Industry.
- Experienced in Data integrity, checking/reviewing of data/protocols and deviations, problem solving any investigations.
- Project management experience.
- Experience of working within a quality system environment e.g. GMP.
- Writing protocols and reports as per ICH and GMP requirements.
- Understanding of specifications and guidelines for pharmaceutical products development required by regulatory bodies including the MHRA.
- Good knowledge and understanding of current GMP and sterile Pharmaceutical manufacture.
- Good knowledge and understanding of Minitab Software and able to apply statistical analysis to data.
- Good communication skills, be able to engage with customers and deal with challenging conversations.
If this sounds like the right opportunity for you please apply online or contact Bal Panesar on 0121 728 8455 if you have any questions.
your application has been submitted