Job Type: Perm
Job ID: JO-1908-19266
Consultant: Karen McHugh
Are you an QC Team Lead with 5+ years experience in a cGMP environment and proven record of managing teams of API lab support analysts and technical scientists?
If you have the relevant experience, please forward your CV to email@example.com for review or call 353 1 7978720 to discuss in confidence.
QC Team Lead - API - Cork
Our client is a leading Contract Research Organization (CRO), working with pharmaceutical, biotechnology and medical device sectors.
The primary purpose of this role is to lead and manage a team of API lab support analysts and technical scientists to ensure that team is operating at the highest quality and productivity standards, have high morale and retention, and the agreed customer requirements are entirely satisfied and that customer expectations are met or exceeded through effective leadership and quality operational management.
This person will be the key point of contact for the client on a day-to-day basis.
Effectively coordinating and managing members of the team so that productivity, quality, documentation, work schedules, safety and housekeeping is run at maximum efficiency.
Responsible for 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.
Responsible for the development, coaching, motivation, and morale of team members through effective teambuilding and use of reward and recognitions systems celebrating team success.
Responsible for reviewing and approving all relevant documentation and technical data in a timely manner and ensuring that it communicated, documented, and filed accurately.
Responsible for ensuring that work is scheduled and cross training takes place so that the service levels agreed with the customer are achieved. Responsible for amending schedules as required.
Ensure that all analysts are trained and have completed training records for all activites and other training completed.
Responsible for carrying out performance appraisals with staff as part of the overall performance management programme within the organisation.
Responsible for continuous feedback to all members of their team on all items in relation to client or organisational requirements / changes.
Responsible for handling any customer related queries where necessary and liaising with their team and with personnel from other teams to problem solve these queries if needed.
Perform investigations, where required, for API Large Molecule Lab issues etc.
Perform other duties as designated by Laboratory Management.
Support early and late phase Technical Transfer activities through generation of protocols/reports, technical writing, execution of laboratory scale studies and participation in manufacturing operations and NPI initiatives.
Supporting early and late phase product development activities through generation of protocols/reports, execution of laboratory scale studies and participation in Lean Early Development initiatives as required.
Providing expertise to development teams on manufacturing facility design and capabilities, scale-up considerations and GMP operations. Partner with Project Teams to provide input, review and approval support for BLA submissions.
To interpret project plans and timelines for CMC projects and schedule work and experiments to meet these goals.
To assist in manufacturing investigations as required, in particular event, deviations and CAPAs, to help meet product release specifications and timelines.
To execute experimental plans and protocols to support product life-cycle improvements, process validation requirements, technical transfer projects and development activities as required.
To foster a culture of Lean and Continuous improvement within the department and with internal and external partners.
A Bachelor Degree or Masters Qualification or PhD Qualification in Biotechnology, Biopharmaceutical sciences or relevant biological or life science is required.
At least 5 years of GMP industry experience
Excellent leadership skills and at least 3 years’ previous supervisory experience.
Analytical skills to troubleshoot laboratory issues are an asset.
Ability to quickly learn new processes.
Experience in aseptic techniques is required.
Ability to communicate clearly and to form strong working relationships with colleagues.
Willing to operate in a flexible manner and be able to switch priorities at short notice.
Organised, accurate, have strong documentation skills.
Passionate about quality and customer service.
Good communication skills both internally and externally.
Excellent attention to detail
Good communicator - easily communicate findings and recommendations to internal clients.
Permanent Full time position
Benefits include medical insurance, pension and life assurance.
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail firstname.lastname@example.org or phone +353-1-7978720
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