Quality Manager
- Recruiter
- Elevate Direct
- Location
- Durham
- Salary
- Competitive
- Posted
- 18 Jun 2021
- Closes
- 21 Jun 2021
- Sectors
- Scientific & Pharmaceutical
- Contract Type
- Contract
- Hours
- Full Time
Job Purpose
Directly responsible to the Microbiology Operations manager for management of projects and performance of validation protocols. To ensure all aspects of the operation or projects within the team's field/s of expertise are performed and to ensure compliance with regulatory and company expectations are maintained. Direct link to the Microbiology technical standards team, and Technical experts.
Key Responsibilities (No More than 10 Bullet Points): Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role.
Responsibilities applicable to all roles at Barnard Castle PSC site:
To work as a flexible and motivated member of the team. To follow all Standard Operating Procedures (SOPs) and/or Standards of Work (SW) applicable and in which the individual has been trained. To act at all times in compliance with Good Manufacturing Practices (GMP) and to report any quality issues. To act in a safe manner, always (in compliance with the Health & Safety at Work Act, and all other relevant legislation) and to use GSK safety reporting systems to highlight potential hazards. To remain up to date with all training requirements (both classroom' courses and computer- based training through the My Learning' internal platform). To take part in Continuous Improvement (CI) activities to highlight improvements to equipment and processes. To take part in Root Cause Analysis (RCA) and Corrective and Preventative Action (CAPA) processes.
Responsibilities applicable to all Managerial Roles at Barnard Castle PSC site:
To ensure development of the team, GPS standards of work and data trending activities are visibly demonstrated. Management of the team in line with all GSK and Barnard Castle Specific policies and procedures, liaising effectively with central and site HR to be compliant and mitigate risk. Responsible and accountable for following GSK recruitment process with the support of the central recruitment team. Demonstrating a fair, professional and inclusive process. Feeding into the site's Strategic Workforce Planning, through strong succession planning and performance management. To operate in line with GSKs leadership expectations and promote correct behaviours and ways of working to their team and other employees. Adhering to the performance management system, holding regular structured performance meetings with all employees in their reporting line, to review development items, recognize success and offer support where required. They will be expected to manage underperformance in a reasonable time frame in line with the GSK performance management policy in a fair and concise way, with an ultimate aim to improve their overall performance. Establish a fully trained and capable team which are high performing and forward thinking to achieve results and protect productivity, whilst remaining compliant. Align themselves and their teams to site priorities, business objectives through effective team leadership and stakeholder management. Manage team budget in line with forecast
Job Specific Responsibilities:
Management of project and validation support across capital and NPI projects. Ensure provision of resource for BI and thermal mapping activities. Provide direct support and management of team to satisfy agreed service levels with the Sterile Business Unit. Provide leadership, perform investigations and generated associated documentation within areas of expertise. Provide leadership and input to site projects where required, ensuring costings are cross-charged as appropriate. Represent the department in communication with external regulatory bodies and facility-based audits. Maintain awareness of regulatory requirements, changes in requirements and incorporate as necessary within microbiology. Ensure techniques and practices are maintained in line with current regulatory and industry best practice. Ensure methodology is robust, compliant and validated. Direct line management of staff, ensuring staff development and performance is optimized by acting as a mentor, assisting with the provision of development plans for relevant staff. Provide coaching in technical and regulatory procedures as required. Ensure staff development and training is optimized and clear objectives are in place. Ensure staff have the necessary support required to perform project and NPI activities within the required timescales. Provide resource planning related to NPI activities and ensure validation performed to schedule. Escalate resource issues and agree prioritization. Liaise with project planners to ensure all Microbiology activities are included in project plans and provide updates as necessary. Ensure all staff can work in a safe environment and any new processes/products/materials to site are appropriately assessed for safety. Work with the Microbiology technical standards lead to ensure all project and validation activities are performed to schedule. Work with the micro Technical Standards team and Technical Experts to ensure mentoring in technical and regulatory procedures as required
If you match these requirements, please apply and Elevate will send you an email. Please open, click and complete required tasks so your application will be visible to the hiring organisation directly.
Elevate is a software partner and not a recruitment agency. Please contact employers directly through your Elevate profile with any queries related to your application.
Directly responsible to the Microbiology Operations manager for management of projects and performance of validation protocols. To ensure all aspects of the operation or projects within the team's field/s of expertise are performed and to ensure compliance with regulatory and company expectations are maintained. Direct link to the Microbiology technical standards team, and Technical experts.
Key Responsibilities (No More than 10 Bullet Points): Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role.
Responsibilities applicable to all roles at Barnard Castle PSC site:
To work as a flexible and motivated member of the team. To follow all Standard Operating Procedures (SOPs) and/or Standards of Work (SW) applicable and in which the individual has been trained. To act at all times in compliance with Good Manufacturing Practices (GMP) and to report any quality issues. To act in a safe manner, always (in compliance with the Health & Safety at Work Act, and all other relevant legislation) and to use GSK safety reporting systems to highlight potential hazards. To remain up to date with all training requirements (both classroom' courses and computer- based training through the My Learning' internal platform). To take part in Continuous Improvement (CI) activities to highlight improvements to equipment and processes. To take part in Root Cause Analysis (RCA) and Corrective and Preventative Action (CAPA) processes.
Responsibilities applicable to all Managerial Roles at Barnard Castle PSC site:
To ensure development of the team, GPS standards of work and data trending activities are visibly demonstrated. Management of the team in line with all GSK and Barnard Castle Specific policies and procedures, liaising effectively with central and site HR to be compliant and mitigate risk. Responsible and accountable for following GSK recruitment process with the support of the central recruitment team. Demonstrating a fair, professional and inclusive process. Feeding into the site's Strategic Workforce Planning, through strong succession planning and performance management. To operate in line with GSKs leadership expectations and promote correct behaviours and ways of working to their team and other employees. Adhering to the performance management system, holding regular structured performance meetings with all employees in their reporting line, to review development items, recognize success and offer support where required. They will be expected to manage underperformance in a reasonable time frame in line with the GSK performance management policy in a fair and concise way, with an ultimate aim to improve their overall performance. Establish a fully trained and capable team which are high performing and forward thinking to achieve results and protect productivity, whilst remaining compliant. Align themselves and their teams to site priorities, business objectives through effective team leadership and stakeholder management. Manage team budget in line with forecast
Job Specific Responsibilities:
Management of project and validation support across capital and NPI projects. Ensure provision of resource for BI and thermal mapping activities. Provide direct support and management of team to satisfy agreed service levels with the Sterile Business Unit. Provide leadership, perform investigations and generated associated documentation within areas of expertise. Provide leadership and input to site projects where required, ensuring costings are cross-charged as appropriate. Represent the department in communication with external regulatory bodies and facility-based audits. Maintain awareness of regulatory requirements, changes in requirements and incorporate as necessary within microbiology. Ensure techniques and practices are maintained in line with current regulatory and industry best practice. Ensure methodology is robust, compliant and validated. Direct line management of staff, ensuring staff development and performance is optimized by acting as a mentor, assisting with the provision of development plans for relevant staff. Provide coaching in technical and regulatory procedures as required. Ensure staff development and training is optimized and clear objectives are in place. Ensure staff have the necessary support required to perform project and NPI activities within the required timescales. Provide resource planning related to NPI activities and ensure validation performed to schedule. Escalate resource issues and agree prioritization. Liaise with project planners to ensure all Microbiology activities are included in project plans and provide updates as necessary. Ensure all staff can work in a safe environment and any new processes/products/materials to site are appropriately assessed for safety. Work with the Microbiology technical standards lead to ensure all project and validation activities are performed to schedule. Work with the micro Technical Standards team and Technical Experts to ensure mentoring in technical and regulatory procedures as required
If you match these requirements, please apply and Elevate will send you an email. Please open, click and complete required tasks so your application will be visible to the hiring organisation directly.
Elevate is a software partner and not a recruitment agency. Please contact employers directly through your Elevate profile with any queries related to your application.