Reporting to the Quality Assurance Manager
Main Purpose of the Job:
Manage all Microbiology activities in the laboratory as well as in the Compounding facility, thus ensuring compliance with all relevant local guidelines and incorporation of global requirements as needed.
Develop systems and monitoring methods that adequately monitor the classified areas within the Compounding facility and the Microbiology laboratory thereby ensuring that the production of products that are consistently meeting the desired quality parameters.
Develop and motivate direct reports ensuring optimal performance levels are attained and maintained
Key Performance Areas:
Management of Microbilogy laboratory:
Manage all routine testing that is required and ensure that results are communicated timeously so that product releases are not unnecessarily delayed.
Implementation and maintenance of a system for ordering consumables to ensure that there is sufficient stock to perform routine duties within the laboratory and in Compounding.
Ensure that all required SOPs and systems within the laboratory are in place and maintained, updated as needed thus complying to local regulatory requirements and adherence to any required global systems/processes.
Identify any new requirements, suggest corrective action required for new requirements, implement and maintain new requirements. Ensure that any applicable CAPAs, events and change controls are closed within the stipulated timeframes, or valid reasons for extension of due dates supplied
Systems to monitor and control environment in classified areas:
Implementation and maintenance of an environmental monitoring program / contamination control strategy within the classified areas that complies to all cGMP and regulatory requirements, taking global requirements into account.
Reporting on EM results and trends that occur within the classified areas, make recommendations, suggest required corrective actions needed, implement corrective actions where relevant and monitor effectiveness of corrective actions, changing corrective actions if insufficient.
Implement international requirements/improvements in methods and systems, making recommendations for local environment if applicable.
Assist departments with projects where Microbiology will have an impact on continuous improvement.
Manage the facility's pest control regime, service provider assessments and report annually on trends and deficiencies in the facility with regards to pest control.
Management of Staff:
Draft or update job descriptions of relevant jobs as the needs of the department and the organization changes.
Draft performance contracts with staff by setting clear key performance areas (KPAs) annually or as required.
Draft and communicate training needs of staff by analysing previous employee performance and identifying performance gaps on an ongoing basis
Manage and provide ongoing performance feedback to staff as required.
Implement the performance evaluation process by scheduling performance reviews with staff, leading the performance discussion and completing the performance reviews annually.
Manage the department’s recruitment needs by liaising with HR to ensure that recruitment is reflective of Employment Equity targets as required.
Manage the department’s leave by making sure all staff leave has been applied for electronically and approved as discussed and as required.
Manage the compliance of policies and procedures within the department by ensuring policies and procedures are effectively communicated to the team as required.
Ensure appropriate disciplinary action is taken as required.
Budget Management:
Setting and reviewing annual OPEX and CAPEX budgets.
Monitoring adherence to budgets, making quarterly adjustments as needed during forecast meetings.
Forecast spending in advance especially at year end ensuring accrual is made as needed
Quality Control:
Release of Critical consumables for the CC facility ensuring all critical consumables meet quality standards.
Improvement Projects:
Initiate and assist with improvement projects to ensure compliance with local global and regulatory standards.