Analytical Services Supervisor
New role for an Analytical Services Supervisor in a fast growing pharmaceutical company. Reporting to the Analytical Services Manager, the Overall purpose of this role is
- The role holder will be provide a supporting role to the Analytical Services Manager in all technical aspects and oversight of the individual departments of raw materials, stability, training, finished product as a stand-in for the Analytical Services Manager.
- The role has responsibility for the oversight and management of a team of laboratory analysts who specialise in the testing and release activities for API (Active Pharmaceutical Ingredients) raw materials, intermediates and finished products.
- The role holder will be a highly organised professional with key strengths in planning, coordinating and control of laboratory operations.
- Being an experienced collaborator, communicator and people manager are key attributes required for the successful performance of the role.
Key areas of responsibility:
- Lead a team of laboratory analysts with a core focus on picking and growing talent, providing candid feedback on strengths and needs, as well as being invested in the development of employees.
- Fostering a culture of learning, development and compliance in the analytical services department
- Samples may originate from equipment swabs, water, detergents, packaging materials, raw materials, in-process and finished product, investigational, complaint, development and any other approved samples.
- Analytical test methods include Physical, Chemical, Organoleptic and other approved test methods, such as chromatographic and wet chemistry.
- Interpret analytical results and data in line with cGMP and company timescales.
- Report analytical results in accordance with cGMP and company timescales.
- Organisation of laboratory, work flow and people.
- Report/ Protocols writing and approval of documentation.
- Maintain laboratory instruments and systems in such a condition as to comply with current GMP requirements for Data Integrity. Inform senior management of any deficiencies noted with regard to compliance
- Daily testing schedules are defined on the basis of ongoing discussion with Production Department, Planning Department and Management. Available resources, (people and equipment), are allocated to meet required schedules. Collaboration and communication with other laboratories is constantly maintained, to ensure targets are not compromised, and that the overall effectiveness of the analytical services laboratory is maximised. Potential shortfalls in resource are identified immediately to Senior Management. Stocks of laboratory standards, chemicals and reagents are monitored and maintained, to support the timely completion of testing schedules. This requires effective co- ordination with other departments and third party suppliers.
- The role holder continuously monitors performance standards within the analytical services department to ensure compliance with Standard Operating Procedures, cGMP and Health and Safety requirements. This requires a comprehensive knowledge and understanding of the methods of analysis performed and relevant Regulatory and Health and Safety standards. Breaches of standards and other incidents are investigated and remediated, with further employee training provided where needed.
- Products for which the final analytical results comply with specification are approved for further processing, when the job holder is satisfied that all company and cGMP standards with regard to analytical testing have been met. This requires the role holder to possess a complete understanding and knowledge of all products and associated analysis.
- Reviews of analytical data and discussions with other supervisors and analysts may reveal non- compliance with specification, OOT results, or problems with methodology or equipment, that may influence or bias the final analytical result. Based on the role holder’s knowledge of the employees involved, materials, products and methods, preliminary investigations are performed to identify the cause as either laboratory or non-laboratory error. Discussions will be performed with management to identify any requirement for additional investigation.
- Creating and managing the training system for the analytical services department to ensure that all analysts are trained to the highest standards in compliance with regulatory requirements. This work involves identifying learning needs, designing and delivering training programmes, recording analyst competency levels and progression of learning activity on the company learning management system.
- Perform any other ad-hoc duties as assigned by the Analytical Services Manager
Qualifications & Experience
- Bachelor/Master degree in Chemistry or other appropriate discipline and a minimum of 10 years' experience in GMP pharmaceutical manufacturing.
- Minimum of 5 years’ experience as a people manager in a laboratory environment.
- A thorough understanding of current cGMP, Health and Safety and COSHH regulations.
- Demonstrated supervisory and interpersonal skills.
- Compliance to all policies, procedures, ethical standards and processes
- Experience in managing diverse relationships.
- Excellent technical writing skills.
- Passion for learning, development and empowering others through learning.