Key Responsibilities include, but are not limited to;
- Ensuring Laboratory Documentation and Computerized Systems compliance with Data Integrity policies and regulatory requirements.
- Understanding Regulations and business processes required to maintain Laboratory Data Integrity.
- Ensuring timely completion of all laboratory analysis assigned to shift.
- Ensuring that analysts working in the assigned cell or team are performing to the best of their ability, coaching and providing guidance where issues occur such as poor set-up or test execution performance.
- Improving the overall efficiency and velocity within the assigned team.
- Identifying and implementing improvements in analytical practices using ‘Zero, Believe it, Achieve it’
- Ensuring that the agreed test schedule is adhered to and identifying recovery paths to bring test schedules back into alignment with plant requirements.
- Identifying weaknesses in laboratory performance and working with the laboratory management to rectify.
- Supporting & initiating analytical OOS issues as they arise in a timely manner both through practical work and through the quality system.
- Ensuring 6S excellence is maintained across the Laboratory.
- Instilling a quality culture of Zero, Believe it, Achieve it amongst the laboratory team
- Ensuring that all laboratory test equipment is utilised and maintained correctly.
- Executing and / or supporting projects through the Lab Management team.
- Maintaining up-to-date, complete and precise records of all tests performed.
- Developing expertise and understanding of current and future analytical techniques.
- Developing and changing of in-house laboratory procedures as appropriate.
- Carrying out verification of testing records & generation of Final CoA as necessary.
- Positively contribute to departmental programs such as CI, BEx and RFT.
- Supports the transfer of new products to the QC Laboratory.
QUALIFICATIONS
So, what do you need to do this role?
- You will have a 3rd level qualification in a relevant Science discipline.
- Minimum 2 years analytical experience in the pharmaceutical industry.
- Proven track record in an analytical role. Must be expert in HPLC, GC, and Identification techniques.
- Strong knowledge on regulatory requirements.
- Proficient in using analytical equipment in a QC lab.
