The Role
As a Quality Control Laboratory Lead, you will manage laboratory resources and budget to ensure the appropriate level of support and prioritization for manufacturing activities and timely delivery of products to customers.
Key responsibilities:
Day to day supervision of the microbiology laboratory to ensure that:
* All routine QC testing is performed in a timely manner in line with agreed schedules. - Calibration, validation, training and other relevant laboratory processes are conducted on time and in line with company procedures.
* Coach staff on standard testing and evaluation processes to ensure best practice for product testing and validation are embedded.
Day to Day management of the following activities:
* Raw material, In-process and finished goods testing in Quality Control Laboratory.
* Management of consumables and materials used in testing.
* Ensure laboratory equipment is working/calibrated/validation.
* Ensure all documentation and testing is completed on time to ensure timely batch release.
* Manage laboratory resources and budget to ensure the appropriate level of support and prioritization for manufacturing activities and timely delivery of products to customers. - Provide support to the Stability team for the annual and product related stability trials. - Provide support to global Customer Quality through completion of complaint investigations.
Training
* Coordinate training of QC staff and new starters.
* Maintain sufficient cross training to ensure coverage of all testing requirements. - Ensure own and laboratory operators training records are complete and accurate.
Validation
* Ensure the validation of test methods, equipment and processes owned by QC, including transmittal of scheduled validation & requalification data to the SVMP.
* Generation of documents, protocols and reports capturing validation activities.
* - Ensure the Validation Master Plan is up to date and being correctly followed regarding Microbiology items.
Quality Documents
* Ensure that relevant documentation, in the form of procedures and specifications are implemented and followed to guarantee compliance with ISO 13485, FDA QSRs the Medical Devices Directive / Regulation and ISO 14001.
* Responsible for compliance of test procedures, company policies, lab-books, raw data and reports in accordance with all relevant procedures
* Lead, support and complete laboratory investigations, CAPA, NC and OOS (Data Deviation) investigation.
* SME on issues pertaining to the QC laboratory for all internal and external audits. - Implement and drive adherence to all local, corporate and industry procedures (for example risk management, FMEA, HS&E, COSHH/Chemical Handling, regulatory, quality).
General
* Contribute to cross-functional teams for part or full projects, changes or other relevant projects.
* Collaborate with other Departments to ensure the timely approval of product & resolution of issues.
* Attend planning and scheduling meetings.
Quality and Compliance Related Responsibilities
* Ensure that all activities are carried out in compliance with all regulations and laws governing business and quality operations. - Responsible for ensuring staff and company
* compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance.
Your Profile
Essential skills/knowledge/experience:
* Ability to communicate & present (in all its forms) and co-operate effectively at all levels across the organization.
* Attention to detail
* Ability to prioritize all work being conducted in the laboratory and to work to deadlines.
* Ability to cope under pressure and to react to changing requirements.
* Ability to work effectively as part of a team to achieve results.
* Ability to manage their own time and workload and to work independently using their own initiative (Excellent time-management) Team performance management on regular
* basis
* Credo Values: Integrity & Credo Based Actions.
* Customer Focus: Results & Performance
* Driven & Sense of Urgency
* Talent Development: Collaboration, Team building, & Self-Awareness & Adaptability.