The candidate must have a sound technical knowledge of analytical techniques and knowledge of related laboratory equipment in one or more of the following areas: Chemistry, Biochemistry or Microbiology. The candidate must have prior supervisory experience of working in an IMB/FDA regulated facility.
The individual will be responsible for:
• Qualification of analytical equipment and related testing functions such as HPLC, Spectrophotometry, Atomic Absorption and Total Organic Carbon etc.
• Sampling and testing coordination during plant and laboratory utility qualification.
• Co-ordinates & plans activities related to the successful transfer of Analytical Methods for relevant new product introductions
• Co-ordination of Raw material, Utilities, In Process and Final product analytical testing and sampling.
• Implementation of Analyst Training programs.
• Responsible for Stability and Retain programs.
Partners with other Departments to ensure that activities related to QC are completed in an efficient manner.
Actively participates in management of the Quality Control Department through budget forecasting and preparation, training of staff, and deputizing for other members of the department management team as appropriate.
ESSENTIAL DUTIES AND RESPONSIBILITIES (Include the following. Other duties may be assigned). Provides leadership in the development and management of the QC function through:
• Motivating and developing reports in addition to developing and setting measurable and challenging goals for the group.
• Reporting on Key Performance Indicators for the group.
• Executing the relevant areas of the Lab Validation Master Plan (LVMP).
• Managing the laboratory testing associated with Raw material, Utilities, In Process, and Final Product samples.
• Qualifying external testing laboratory services, including transfer of analytical methods and laboratory certification.
• Implementing training programs for QC analysts in order to perform testing of Raw material, Utilities, In Process, and Final Product samples.
• Reviewing and approving relevant QC SOP’s.
• Anticipating and planning for future requirements in the area.
• Ensuring QC activities are carried out in compliance with cGMP and company quality and safety standards.
• Participating in relevant internal and external QC related audits.
• Developing and implementing safety procedures within the laboratory.
• Deputizing for the QC Lead as appropriate
• Manages and develops staff reporting to the position.
• Communicates effectively so that all relevant stakeholders are kept informed of potential bottlenecks, resource requirements and project progress.
• Establishes effective partnerships with other individuals, departments and affiliates so that QC activities are well understood and coordinated.
• Represents the laboratory where appropriate in meetings and other communications with regulatory authorities, industry meetings, etc.
• Maintains and develops knowledge of analytical methods and technology as well as GMP and GLP
Content will be erased after question is completed.