Microbiology QC Team Leader

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Date: May 16, 2019

Location: Braine L'alleud, Walloon Brabant, BE

JOB SUMMARY          

 

SCOPE

- Supervision of Microbiological analytical activities from development to commercial including release, stability and project support.

 

NATURE

1. The function will manage the techician team to ensure analyses and double check on due time in a safe working environment.

3. This function will be the QC representative for microbiology analysis.

4. The function will build strong analytical knowledge for Phase I and commercial products.

5. The function will lead a continuous improvement program and ensure follow-up.

6. The function includes the management of regulatory aspect linked to activities, ensure the interface between the laboratory and Regulatory Affairs, and insure that testing is compliant to regulation requirement updates.

7. The function is key to increase expertise in the lab by training technicians to analytical techniques and support troubleshooting.

 

 

MAJOR ACCOUNTABILITIES

 

HSE

1. Apply the company's Health and Safety policy within the laboratory.

2. Ensure a safe working environment to meet site safety objectives.

 

MANAGEMENT

1. Motivate, recognise team members performance, maintain discipline and compliance to rules whilst firmly supporting team work and spirit. Manage conflicts.

2. Increase team’s competency by ensuring adequate training, coaching and development of technicians.

3. Define and communicate openly the objectives of individuals and of the team in accordance with the company’s strategy and formally assess the results with the adequate KPI (Key Performance Indicators) covering HSE, quality and overall performance both for the individuals and the team.

4. Ensure continuous feedback and end year performance review of each team member as well as their contribution to the team in time in full.

5. Ensure job descriptions & training plan of people are in lign with the organisation.

6. Be back-up of the Microbiology & E.M head.

 

OPERATION

1. Ensure the day-to-day operational planning and coordination in order to satisfy the stakeholders needs.

2. Organise daily meetings with team to follow-up on the planning and collect / give informations. Ensure that each team member contribution is done in due time. Escalate information to the Microbiology & E.M head.

3. Ensure that corrective actions are taken and put in force in due time.

4. Implement, follow-up and communicate on KPI with its related corrective actions.

5. Inform stakeholders and Microbiology & E.M head of deviations from the day-to day activities.

6. Be prepared and participate actively to stakeholders planning meetings, propose solutions, demonstrate creativity and pro-activity in order to ensure adherence to plan and performance.

7. Lead continuous improvement and ensure that continuous improvement is part of  day-to-day activities of the laboratory.

8. Ensure that lab infrastructure including facilities, utilities & equipments are well maintained.

9. Maximize the utilisation of departements budget within given budget limits.

10. Ensure an efficient interface with customers : Chemical, Pharmaceutical (commercial & development) and Packaging Plants, QA/RA (validation), Metrology (calibration), BPS, HSE (Security and Environment), HR (Human Resources), CoE (Centers of expertise)…

11. Participate to the elaboration of new project related to microbiology.

 

QUALITY

1. Ensure update of procedures and instructions in due time.

2. Ensure resolution & follow-up of corrective actions and preventive actions. Ensure audit readiness, participate to the preparation, the follow-up and the realization of audits.

3. Ensure the follow-up of déviation / OOS and take actions to reduce the number of laboratories déviation / OOS.

4. Ensure adequate training/coaching of technicians linked to the analytical activities requested and performed.

5. Guarantee that the analysis runs in compliance with the existing process and product norms, procedures and instructions and especially the GMP.

 

 

COMPETENCIES

 

1. Motivate, recognise team members performance, maintain discipline and compliance.

2. Firmly supports team work and spirit.

3. Manage conflicts.

4. Act as a coach / mentor & evaluate performance of individual and team.

3. Communicate openly.

4. Ensure continuous feedback and promote feedback culture.

5. Promote initiatives for improvement.

6. Has a strong knowledge in operationel management.

7. Has a strong knowledge in pharmacopoeia methods & GMPs in pharmaceutical microbiology laboratory (sterility testing, bioburden testing, endotoxin testing, identification of germs, testing for total aerobic count and specified germ search, challenge tests…).

8. Has a knowledge in operational excellence & microbiology lab management.

9. Be responsible to contribute to elaborate & manage budget.

 


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