Compliance Officer

2 months ago

East London, South Africa Aspen Pharma Group Full time

**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**
- 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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