Senior Manager - QC Analytical Operations

Recruiter
Location
Dublin, Leinster
Salary
Competitive
Posted
12 July 2018
Closes
09 August 2018
Position / level
Manager, Professional
Contract Type
Permanent
Hours
Full Time

The Role

The Senior Manager for QC Analytical testing is responsible for all analytical testing associated with finished product, stability samples and raw materials at Forest Laboratories Ireland.

The Senior Manager for QC Analytical is responsible for providing guidance and direction to Quality Control supervisory staff in their daily oversight of quality control processes and accountabilities and ensures the QC laboratory personnel perform their duties in compliance with all applicable laws, regulations, GMP, and internal Company policies.  The position reports to the Associate Director of Laboratory Operations and may act as a deputy for the AD for Laboratory Operations in their absence.

Key Responsibilities:

  • Ensure the functions of the Quality Control laboratory associated with analytical testing referenced above are completed in a timely and efficient manner.
  • Identify and prioritize resource requirements in association with the Assoc. Director for Laboratory Operations based on project plans and time lines and allocate and schedule resources to meet regulatory and commercial requirements.
  • Establish the expectation and standards, and the supportive environment, to ensure that the analysts and reviewers involved in the Analytical group have the capability to meet performance expectations. 
  • Manage the testing of raw materials, intermediates, stability samples and finished products.
  • Maintain accountability for Analytical group performance metrics around product and raw material testing.
  • Ensure all generated data reports from the Analytical testing group are current, accurate, and distributed according to defined procedures.
  • Ensure continual improvement of all associated documentation (SOPs and ‘On the Job’ aids) and that they are current, accurate, and clearly define process and role responsibilities.
  • Encourage process innovation and continuous process improvement in the QC Analytical function.
  • Ensure that routine testing operations for finished product, stability and raw materials are in compliance with HPRA, FDA, ANVISA and other country regulations as appropriate.
  • Represent the QC Analytical function with all internal stakeholders. 
  • Implement / execute QC goals consistent with Forest local site goals and strategy. Develop plans to achieve those goals and prioritize and execute those plans in conjunction with Assoc. Director for Laboratory Operations.
  • Act as delegate for the Associate Director of Laboratory Operations in their absence

Candidate Profile

Education:

  • Bachelor’s Degree or above in Analytical Chemistry or Instrumentation

Experience:

  • At least 10 years relevant analytical experience.
  • At least 3 years of relevant supervisory experience.
  • Demonstrated success in managing a team in a pharmaceutical testing environment
  • Experience in managing by metrics or working to strict timelines.

 

 

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