Description
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.

Requirements
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