Description:

Our client, a leading Pharma Company based in Waterford requires an Analytical Development Team Leader for their R&D Team who will support product Development and Clinical Supply by ensuring that all project plans and milestones are delivered on time and in full. The Analytical Team Leader will also be responsible for ensuring that all analytical methods are developed and validated in accordance with regulatory requirements and ensure all raw materials and finished products are tested to agreed schedules.

Minimum Qualifications and Experience:

• Post graduate qualification in Chemistry, pharmaceutical Science or related discipline
• At least five years’ experience working in a related technical environment
• At least two years’ supervisory/management experience is desirable.
• Project management skills
• Previous experience of regulatory and customer inspections

Responsibilities:

• To actively plan each new development project in conjunction with the Analytical Services Manager and relevant Project Manager ensuring major milestone targets for each project are visible to all team members and key stakeholders to achieve on time market entry.
• To determine tasks and resources in conjunction with the Analytical Services Manager required to deliver each project milestone 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 to clarify situations before deciding a way forward taking all the facts on board. To gain agreement from partners to support or take action which supports or builds the partnership; using sound rationale to explain value of actions.
• 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. If a procedure does not exist, devise one (through the appropriate channels); if a process needs amending, do so through the appropriate channels.
• To lead Laboratory investigations (Incident Reports, Out of Specifications etc)
• To assist in the preparation for customer /regulatory inspections.
• To support all other on-going laboratory functions & requirements.
• To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
• To troubleshoot, develop, transfer and validate robust, sound analytical methods.
• To review test methods, protocols and reports as applicable.
• To prepare Submission Documentation in support of licence applications.
• To manage day to day scheduling of laboratory activities and capacity management.
• To ensure that all raw materials, in process samples and finished products are released in a timely and efficient manner and ensure quality and efficacy of the product.
• To perform additional tasks as agreed to support the effective running of the business.
• To support all other on-going laboratory functions & requirements.
• To ensure requirements of companies Safety Statement are implemented.
• To continuously promote a positive safety culture by leading by example.
• To implement safety requirements as per site documentation including SOP’s, Safety Statement and COP’s.
• To perform H&S inspections and attend relevant meetings.
• To report any defects/hazards.