The primary purpose of this role is to lead and manage an off-site Professional Scientific Services team of analytical staff to ensure that customer requirements, quality requirements, and organisational goals are met. This person will be the key point of contact for both our client's PSS Team and also the client on a day-to-day basis.
In general the Lead Analyst is expected to spend 25% of their time on leadership duties, and 75% of their time on laboratory based activities
- Laboratory set up with responsibility of drafting SOPs and EM specific SOPs
- Liaise with other divisions such as Operations, QA and Projects on authoring HVAC qualification protocols
- Author EM SOPs, EM methods, area SOPs containing site sample map information
- Oversee the purchase and vendor qualification of viable and non-viable EM air samplers
- Schedule the execution of HVAC qualification Environmental monitoring identifying efficiency opportunities in the process
- Action the environmental monitoring associated with the HVAC qualification protocols
- Prepare a routine EM program to start once HVAC PQs complete and continue the routine EM in these areas at a routine frequency while other areas continue to be qualified in a staggered approach.
- Order and control irradiated pre-poured media plates required for EM. Including co-ordination of quality checks and release for use of the media (growth promotion performed offsite by a third party)
- Provide support and subject matter expert knowledge in investigations associated with deviations
- Become a subject matter expert knowledge in investigations related to deviations and provide support on these matters
- Work with the PSS Manager to effectively coordinate and lead the PSS team so that productivity, quality, documentation, work schedules, safety and housekeeping are run at maximum efficiency
- Notify the client representative, any anomalous or out of specification results and participate in the investigation as appropriate.
- Ensure all records presented for review and approval are at the required standard and hold responsibility of completing training records
- Training provision to other team members as necessary. Ensure all training actioned are documented appropriately.
- Being constantly aware of client's requirements and striving to meet or exceed those requirements keeping in mind the client process end points.
- Reviewing and approving all relevant documentation in a timely manner and ensuring that it is communicated, documented, filed accurately, and compliant with the required standards.
- Maintain a clear understanding of the client relationship and service goals and help others achieve the same.
- Engaging with client and dealing with queries. Contact designated personnel with any relevant information or issues relating to test results or the service in general.
Education / Skills
- A Degree in Microbiology or a related discipline is required.
- A minimum of 3 years' relevant experience of environmental monitoring within a GMP environment
- At least 1 years' experience in a supervisory/leadership capacity is an advantage
- Willing to operate in a flexible manner and be able to switch priorities at short notice.
- Ability to communicate clearly both internally and externally and to form strong working relationships with colleagues.
- Ability to work in a lab environment with some supervision and be capable of developing solutions to problems.
- Good team player, organized, accurate, have strong documentation skills.
- Passionate about quality and customer service.
This is a great opportunity to join our award-winning team partnering with one of the world's top pharmaceutical companies.
This position is full-time and permanent and the working week is 39hrs (Mon-Fri) but there is the potential that occasional weekend work would be required. Salary is competitive and benefits include Medical Insurance, pension and life assurance.
Search is an equal opportunities recruiter and we welcome applications from all suitably skilled or qualified applicants, regardless of their race, sex, disability, religion/beliefs, sexual orientation or age.