Quality Control Operations manages and executes all routine testing using validated analytical methods and following prescribed testing plans. Test results allow to monitor and drive the manufacturing processes, release the product or material, determine shelf life of the product or material and assess potency, quantity, identity and safety against defined specifications.
QC manager (Operations) leads a team of QC scientists covering one of 4 shifts. Job holder is responsible for efficient provision of QC services to production and other internal and external customers by overseeing testing schedules, schedule adherence and establishing effective communication between all stakeholders. QC managers monitor, maintain and improve compliance within the team and across the department. QC managers interact with multiple functions within the business to guarantee smooth and concise information exchange.
Please note, that this is a full-time shift-based role covering either Sunday to Wednesday / Wednesday to Saturday with bi-weekly shift rotation between earlies (6AM - 345PM) and lates (1215PM -10PM).
Key Responsibilities
* Ensuring adherence to health and safety policies and procedures within the team
* Managing team of QC Scientists (performance assessments, improvement and development plans)
* Establishing SMART objectives for the team members and continuous progress monitoring
* Managing QC schedule (creation, adherence) to ensure timely delivery of results to production and allow timely batch certifications
* Managing workload and capacity for the team and assigning adequate priorities
* Maintaining the QC laboratory in inspection ready state
* Ensuring adequate training level within the team
* Collation and presentation of team metrics
* Maintaining and improving the state of compliance within the team (e.g., adherence to procedures)
* Managing the batch certification process (e.g., data review, approval, quality events)
* Developing and implementing continuous improvement projects
* Looking after the wellbeing of the team
* Coordination of shift activities with Production counterparts
* Cooperation with other QC managers to ensure testing and compliance continuity
* Execution of self-inspections within QC and implementation of CAPA
* Cooperation with Validation and Engineering to ensure GMP status of analytical instruments and QC facilities
* Working closely with QA to efficiently manage all aspects of quality and compliance related to Quality Control
* On call for EMS system in QC laboratory
* Any other duties as required following consultation with the post holder
* Work in adherence to local Health and Safety policies and SOPs
Demonstrated skills and competencies
E – Essential
P – Preferred
Experience
* Min 3 years industry experience as a manager in GxP regulated environment, preferably in ATMPs or Biopharmaceuticals
Qualifications
* BSc/MSc degree in life sciences (P) or significant relevant industry experience
Skills/Specialist knowledge
* Open to working shifts (E)
* Attention to detail (E)
* Meet requirements to work in cleanroom environment (P)
* Excellent spoken and written communication (E)
* Influencing skills (E)
* Excellent time management (E)
* Ability to precisely follow procedures (E)
* Conflict resolution skills (E)
* Familiarity with GMP regulations relevant to Quality Control function (E)
* Familiarity with analytical procedure lifecycle (validation, tech transfer, verification) (P)
* Familiarity with regulations governing stability testing and shelf-life management (P)
* Familiarity with analytical equipment qualification lifecycle (P)
* Experience with QMS quality events (application, conduct, timely closure) (E)
* Demonstrated experience of representing a function at high level cross-functional meetings with minimal support required (E)
* Highly Proficient in MS Word, Excel, Power Point, DOE and any other relevant applications (E)
* Demonstrated experience in mentorship, supervision, and management of experienced members of team (E)
* Great ability to identify and implement solutions with minimal direction (E)
* Technical background in Quality Control for ATIMPs (P)