Overview
Manage and improve compliance to statutory pharmaceutical and engineering requirements in Engineering department.
Identify, define and lead implement CI compliance initiatives.
Develop and manage engineering training plan.
Responsibilities
Planning and Operational Support
Act as a lead technical expert/ subject matter resource
Optimise and facilitate implementation of current processes.
Identify gaps in current policies and procedures.
Propose changes or improvements to processes, tools, techniques.
Production Facility and Engineering Compliance
Prioritise compliance system workflows to meet deadlines.
Coordinate and manage the SOP review timetable.
Update and implement new and reviewed SOPs with relevant management, adhering to compliance standards.
Assist with writing technical SOPs for department.
Compile and update general SOPs for the facility.
Develop workflows to create, compile, update, review and approve SOPs to maintain adherence to standards and regulation.
Assist with management of Change Control and Deviation system according to standards.
Create Change Control and Deviation reports for Engineering Management and Quality System meetings.
Participate as a representative at Quality System meetings.
Assist with internal and external audit programmes and audit reports.
Follow up on corrective action plans to address minor and major audit findings; assess effectiveness of plans for close out.
Develop and implement improvements to documentation and document practices to ensure compliance.
Manage and coordinate the on-site vs. off-site storage of department GMP and SAP records for quick retrieval.
Analyse compliance statistics and report on trends; identify and implement compliance improvement opportunities.
Develop and manage compliance to engineering training plan.
Train staff on non-technical SOPs to ensure compliance to quality and safety standards.
Reporting and record keeping
Consolidate information for reports on weekly/ monthly basis
Analyse consolidated data and provide recommendations
Compile detailed and standardised reports
Monitor and control access to and set-up of electronic databases
Retrieve supporting documentation and records to facilitate and support query resolution.
Skills Required
Background/experience
Trade Tested Electrical Artisan with 2 to 4 years' post Apprenticeship experience; or National Diploma with 2 to 4 years' related experience
Administrative and Quality Systems experience
Engineering maintenance systems experience
Specific job skills
Advanced knowledge of pharmaceutical quality operations and quality management systems
Knowledge of Pharmaceutical standards and compliance requirements
Ability to interpret and implement policies, processes, and objectives.
Competencies
Interrogating Information
Meeting Deadlines
Finalising Outputs
Maintaining Accuracy
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