Release And Stability Team Lead (R&D)

ICDS Recruitment

Waterford

Release and Stability Team Lead (R&D. Key Purpose: The ideal candidate will be required to support Stability Testing of R&D products by ensuring that all project plans and milestones are delivered on time and in full while also supporting testing of all water samples in the R&D Centre. Also assist other R&D Analytical groups in the testing of In Process and Finished Product samples if required, and ensure all testing is performed to agreed schedules and in accordance with regulatory requirements. The role reports directly to the Analytical Services Manager in the R&D Analytical group. Key Responsibilities. 1. Project Planning : • To actively plan each Stability Program in conjunction with the Analytical Services Manager, relevant Team Lead and Project Manager ensuring major milestone targets for each project are visible to all team members and key stakeholders. • To determine tasks and resources in conjunction with the Analytical Services Manager required to deliver the Stability program milestones by breaking them down into tasks; identify equipment, materials and people needed. • To proactively build effective working relationships with core team and functional members. To attend project review meetings and to provide project plan information. 2. Compliance. • To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOP’s, regulatory regulations and guidelines, safety and environmental guidelines. • To ensure high quality output- To vigilantly watch over job processes, tasks, work products and documentation to ensure freedom from errors, omissions, defects or data integrity issues in order to achieve a high level of customer service and cGMP. • To initiate action to correct quality/schedule problems or notify others of quality issues as appropriate. • To trend and review data for Stability programs and for water testing. • To lead Laboratory investigations (Incident Reports, Out of Specifications, Out of Trends etc. • To assist in the preparation for customer /regulatory inspections. • To review test methods, protocols and reports as applicable. • To prepare Submission Documentation in support of licence applications. 3. To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. 4. To manage day to day scheduling of laboratory activities and capacity management. 5. To ensure that all stability programs/water testing programs are carried in a timely and efficient manner and ensure quality and efficacy of the product. 6. To perform additional tasks as agreed to support the effective running of the business for e.g. assist other R&D groups in the testing of raw materials, in process samples and finished products. 7. To support all other on-going laboratory functions & requirements. 8. Coaching / Mentoring – support members of the team with problem solving and skill development to aid learning and early problem resolution. 9. Recruitment – assist with recruitment of team members in line with resource requirements and to the job spec. 10. To identify training requirements and training of Chemists and organize training as required. 11. Recruit, train, manage, and develop team. Minimum Qualifications & Experience. • Qualified to a minimum of degree level in chemistry, pharmaceutical science or a related discipline. • At least five years’ experience working in a related technical environment. • At least two years’ experience working in a Senior Chemist or Team Lead role is essential. • Project management skills. • Previous experience of regulatory and customer inspection. Key Competencies. • Evaluate situations, calculate and reduce risk, justify and defend correctness, give reasons for views and generally provide shrewd judgement in any situation. • Consider problems as a challenge, collect information relevant to the problem, be disciplined in ascertaining the root cause, identify and develop a practical solution, communicate the findings and implement action to resolve the problem. • Provide the best possible solution to problem solving or decision making by thinking things through. • Search out errors; rectify omissions; perfect systems and procedures which will ultimately raise the quality and standards of all tasks undertaken. • Develop networks and identify resources as and when necessary. • Encourage a high level of performance in self and others. • Adopt an accommodating and helpful manner, debate, agree and where necessary accept the objectives set by others within agreed parameters in order to ensuring tasks are complete. • Be proactive and energetic in the work situation, seeking to get things done and at the same time deal with a variety of tasks. This job originally appeared on RecruitIreland.com.

1826 days ago