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Interim QC Lead

Hertfordshire, United Kingdom

  • Salary: Dependent on Experience
  • Job type: Interim/Contract
  • Posted: 24/07/2019
  • Contact name: Christopher Wise
  • Contact number: 01892 612612
  • Ref: 4569

Job description

Interim Quality Control Lead
 
Purpose of Role:

Reporting to the Head of Quality Control, this role is pivotal in ensuring that the new facility’s QC laboratories and the services they provide meet the standards and expectations of the regulatory authorities and Collaborators.

Key Accountabilities:

QC Laboratory Support:

Primarily environmental monitoring & microbiology (bioburden, rapid sterility by BacT/ALERT, chromogenic endotoxin and mycoplasma by PCR). The role will also include bioanalytical testing (rtPCR, Flow Cytometry etc.) of starting material, in-process samples and final product specification testing. The role is focussed on leading the tactical execution of laboratory analysis and result reporting to assure the QC service provision is maintained in line with the requirements of each collaborator, this will include:

Leadership and line management supporting a growing group of specialists and technicians
Emphasising and maintaining within the team a strong GMP knowledge base and work ethic
Maintaining a comprehensive facility environmental monitoring program
Supporting the Head of Quality Control with project delivery and project management
QC laboratory work scheduling and resource allocation ensuring efficient operation
Technical training and coaching of the Quality Control group
Analytical technical transfer of collaborator methodologies into QC
Establishing a portfolio of Pharmacopoeal tests into QC
Assisting in the recruitment of new employees as the group’s capability expands
Development of QC departmental performance measures, metrics and reporting tools and delivery of the same on periodic basis
Lead Out of Specification Investigations and disposition
Deputise for the Head of Quality Control when required

Microbiology:

Support microbiology test validations and method qualifications.
Act as a subject matter expert for microbiology-related inquiries.
Provide lead for aseptic process qualifications, such as aseptic gowning, good aseptic practices and media fills etc.
Lead microbiological Out of Specification investigations.

Regulatory Compliance:

Ensure the QC function operates to a high standard and complies with cGMP and other appropriate regulatory standards
Support to ensure all QC laboratory equipment is maintained fit for purpose (qualified and calibrated appropriately and with the appropriate degree of periodicity)
Generate, review and approve cGMP documentation such as Standard Operating Procedures, Analytical Test Methods, Analytical Test Qualification protocols and reports etc.
Ensure the team and associated service providers complete all documentation and records accurately, contemporaneously and to a consistent GMP standard
Ensure systems are in place and being followed such that the traceability of all reagents, materials, equipment, standards etc. is maintained for all GMP sampling and testing activity
Participate in Out of Trend, Out of Specification and Deviation management events associated with QC activity and act as collaborator liaison to report and manage such events to an appropriate and compliant conclusion

Experience:

Minimum of 5 years’ experience working at a supervisory level in QC in a GMP licensed aseptic (bio)pharmaceutical manufacturing environment
Proven experience of writing and reviewing GMP documents
Proven experience of looking critically at own and others work practices and procedures and identifying and implementing any needed improvements
Proven experience of motivating teams, whilst training and acting as a role model for employees associated with the GMP QC laboratories
Experience in interacting with the regulatory authorities
Experience in interacting with clients and collaborators

Knowledge / Skills / Competencies:

Highly motivated, pragmatic and practical to support the mission to assist in the acceleration of the development of a commercial cell based therapy industry in the UK
Expertise in the application of EU GMP to QC operations
Expertise in pharmaceutical microbiology
Able to evaluate complex situations and find solutions for them in a professional manner
Project ownership and pride in its delivery
Having a passion for delivering excellent customer service
Flexibility towards work assignments and new learning
Ability to manage multiple and varied tasks and prioritise workload with attention to detail
Comfortable operating autonomously
Excellent interpersonal, written and verbal communication skills
Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives
Having current and up to date professional knowledge, expertise and best practice
Ability to quickly establish credibility and build rapport and trust
A good team player, with strong organisational skills

Education / Qualifications:

Bachelor’s degree in Microbiology, Biotechnology, Molecular Biology, or related discipline
Member of a recognised professional body (Desirable)