Description:
Our Client is a leading contract research organisation providing testing and research services in the pharmaceutical and biopharmaceutical sciences to clients worldwide.
This position is to join their innovative Professional Scientific Services (PSS) programme as an employee of our client.
Job Responsibilities
- Work with the Group Leader to effectively coordinate and lead the PSS shift team so that productivity, quality, documentation, work schedules, safety and housekeeping are run at maximum efficiency.
- Ensuring that the client gets the best possible service by continually reviewing best practice in relation to both commercial and quality issues and ensuring 100% ethical work standards and GMP compliance.
- Development, coaching, motivation, and morale of team members through effective teambuilding and use of reward and recognitions systems celebrating team success.
- Responsible for quality risk assessment of various technical processes, including sampling plans; preparation of validation protocols and subsequent procedures for final approval by client personnel.
- Reviewing and approving all relevant documentation and technical data in a timely manner and ensuring that it communicated, documented, and filed accurately.
- Reviewing and improving commercial work practices. Identify areas where efficiencies may be improved and liaising with the PSS Group Leader and client appropriately about any proposed improvements.
- Forward planning of activities in order to maximise the use of client resources during training periods.
- Ensuring that work is scheduled, and cross training takes place
- Performing all sampling and analyses required to the correct standard and turn-around times.
- Responsible for carrying out performance appraisals with staff as part of the overall performance management programme within the organisation.
- Assist in the training of analysts.
- Write SOP’s, protocols, trending reports on an on-going basis, as required.
- Initiate and investigate non-compliance or out of trend/ specification situations in the laboratory. Liaise with Group Leader to facilitate close out of Lab Investigations and Non-Conformances/Deviations.
- Responsible for handling any customer related queries where necessary and liaising with their team, PSS Group Leader, and with personnel from other teams to problem solve these queries if needed.
- To address group local audit findings in conjunction with the PSS Group Leader.
- To GMP review analytical data.
Education / Qualifications
- A degree in Microbiology or a related discipline is required.
Experience / Skills
- At least 3 years’ experience in a pharmaceutical industry GMP laboratory
- Strong familiarity with GMP and Microbiology.
- Good understanding of Chemistry is advantageous.
- Passionate about quality and customer service.
- Excellent communication skills (internally and externally) and understanding of appropriate client interactions.
- Willing to operate in a flexible manner and be able to switch priorities at short notice.
- Good team player, organized, accurate, have strong documentation skills.