Lab Co-ordination Team Leader

☞ PCI Pharma Services

View: 102

Update day: 30-05-2024

Location: Tredegar Wales

Category: Pharmaceutical / Chemical / Biotech

Industry:

Job type: Full-time

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Job content

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

To support the relevant lab planning activity and all associated routine / non-routine activities, in an effective and efficient manner, whilst maintaining compliance with all Company, Regulatory and Client requirements.
To support the Analytical Operations Test Requirements, plan for all QC testing on a rolling forecast to ensure all client delivery commitments are met.
  • Manage the QC Reporting Team and Metrology departments in line with the business needs.
  • Test Plan Support Metrology Operations Delivery of CofA and Trend Reports
  • Participate in client and regulatory audits and lead Laboratory projects as business need dictates.
  • Support the Analytical Operations Group testing plan in order to ensure cGMP compliance and timely completion of release and stability activities to achievement of client expectations.
  • Liaise with the QC Manager to ensure proactive management of the Test Plan to eliminate delays and collate all test documentation when completed.
  • Metrology department head to deliver the department objectives, including outsource testing.
  • Manage all compilation of the batch paperwork to ensure all requirements are fully met.
  • Support the management of the capacity, capability and resources of all lab equipment, HPLC’s, Dissolution Baths, Karl Fisher etc.
  • Support the Supply Chain Team to clearly define and structure the Delivery Plan (Testing, Checking etc.)
  • Prepare and authorise technical documentation within the team and department, as required.
  • Review analytical and laboratory data within the team/department for accuracy, completion, and compliance with documented procedures. Including Right First Time Trending, Validation VTP’s, Final Data Approvals.
  • Be responsible compilation team generates C of A’s, Trend reports and stability reports on time and trigger the invoicing point.
  • Ensure all AS equipment maintained, monitored and calibrated in line with all instrument qualification protocols, including incubators, fridges/ freezers.
  • Maintain all records for equipment breakdowns to facilitate in depth reports to understand efficiency and ROI on equipment.
  • Co-ordinate all outsourced testing to ensure test results are received in order to meet the client delivery dates.
  • Ensure all standards and components are available to support the Test Plan and maintain KanBan levels Ensuring all KPIs, targets and other deadlines are met consistently both individually and by the team.
  • Maintains Tier SQDC tracking boards. Understands Pareto Charts, identifies action plans, chases down actions, gaining support from resources outside of the department.
  • Team Management & Coaching: - Supports all human resources effectively ensuring recruitment, training, appraisals and discipline are coordinated to reach departmental goals.
  • Works with the management team to maintain records and to consistently, promptly and effectively respond to discipline and motivational issues.
  • Actively gauges moral in the team and takes action to address issues and provide support as required/ as necessary
  • Ensure that all staff within the area of responsibility comply with PCI’s Environmental Health and Safety Policies and Procedures.
  • Ensure that all staff appraisals within the area of responsibility are conducted absolutely on time and in line with PCI’s PMR Policy.
  • Facilitate personal Continuing Professional Development to ensure that the group can provide expertise in the very latest techniques, along with regulatory awareness of new guidance and industry trends on a global and national scale.
  • To manage the training requirements within the group to ensure regulatory compliance and business needs are met.
  • To identify self-development needs. In conjunction with HR, to develop training plans and budgets.
  • To undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities and responsibilities
  • Create and sustain a working environment that promotes the PCI Pharma Services Values and Behaviours.
Join us and be part of building the bridge between life changing therapies and patients.
Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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Deadline: 14-07-2024

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