Title: Head of QualityLocation: North WestSalary: Competitive + BenefitsSRG are currently looking to recruit for a Head of Quality to join a well-established Contract manufacturing...
Quality Control Biologics Team Leader
Salary 50.000 to 60.000euros Job Description:
- To carry out all functions of a Synergy Project Manager, to the highest standards of quality and efficiency representing the best interests of Synergy and the client's project at all times.
- To manage the Synergy QC NBE team to ensure analyses of New Biological Entities supporting release and stability testing;
- To coordinate all requests of analysis (electronic or paper) ask by the stakeholders, to ensure the follow-up and communicate the results;
- To prepare, verify and communicate the weekly planning of the technicians;
- To participate to all meetings with stakeholders in term of planning and samples follow-up;
- To support projects, deviations and investigations within the laboratory.
- Apply the company's Health and Safety policy within the laboratory.
- Ensure a safe working environment to meet site safety objectives.
- Represent the company to the highest of professional standards, both internally and externally.
- Work without supervision, but taking direction from the Synergy Technical Operations Manager.
- Manage a Synergy Team to deliver the project as outlined in the scope of Works that exists between Synergy and the Client.
- Oversighting all aspect of the project planning and execution.Oversight of all project KPIs.
- Primary point of contact of the client management team and Synergy employees.
- Escalate any issues or problems to the Synergy Technical Operation Manager.
- Ensure that all Synergy employees reporting to him/her have a Synergy job description, training plan and objectives in place.Ensure the team are meeting Key Performance Indicators.
- Ensure that all activities performed by his/her team adhere to all client standards (GMP, Safety and Security).Perform appraisals and performance reviews for team.
- Ensure the day-to-day operational planning and coordination in order to satisfy the client needs based on a monthly forecast.
- Organise daily meetings with team to follow-up on the planning and collect and give information. Ensure that each one contribution is done in due time.
- Ensure required corrective actions are taken and put in force.
- Implement, follow-up and communicate on KPI with its related corrective actions.
- Inform stakeholders and/or responsible of the lab if deviations from the day-to-day-planning occur.
- Be prepared and participate actively to weekly/monthly planning meetings, propose solutions, demonstrate creativity and pro-activity in order to ensure adherence to plan and performance.
- Ensure that continuous improvement is part of day-to-day activities of the laboratory.
- Ensure that the lab infrastructure including facilities, utilities and equipment are well maintained.
- Be accountable for a pro-active collaboration with different stakeholders.Quality
- Ensure follow-up and compliance of procedures and instructions, and update if needed
Master's degree required in analytical chemistry (applied to biological products / NBE), biochemistry, biology or equivalent;
- Expertise in the pharmaceutical analysis of, preferably, New Biological Entities and more specifically monoclonal antibodies; Areas of expertise should include: Biotechnology Analytical Chemistry, troubleshooting and protein manipulation (HPLC, Electrophoresis, ELISA, etc.)
- Strong expertise in HPLC/UPLC applied to biological products is preferred;
- Experience in GMP;
- Understanding of all analytical disciplines related to CMC for late stage development and commercial products (analytical development, stability testing and quality control of drug substance, drug product, raw material and intermediate).
- Fluent in English and French.
- Ability to organize the multiple requests and multiple way of request;
- Strong sense of accountability and responsibility, with the ability to manage priorities;
- Ability to work in collaboration with technicians and managers;
- Customer and results oriented.
If this job description is interesting to you, please send your CV to : email@example.com or call 00441618044359 for further information.