Compliance Pharmacist

3 months ago

Port Elizabeth, South Africa Aspen Pharma Group Full time

**Overview**
- Monitor manufacturing compliance to GMP and statutory requirements.
- Monitor adherence to guidelines, procedures, and document controls.
- Manage Production Pharmacists and PMA’s.
- Deliver expected value stream targets as per business requirements.
- Facility GMP compliance.
- Team and process development.

**Responsibilities**

**Staff development**
- Train new Pharmacists and PMAs on SOPs in transition period
- Ensure pharmaceutical and supervisory team training is compliant.
- Oversee staff professional development to ensure team value add is realized.
- Facilitate training sessions as required.
- Mentorship and guidance to pharmaceutical teams

**Product release management**
- Facilitate end to end product release process withing production department.
- Deviation management and adherence to daily, weekly targets.
- Raise deviations, complete forms and investigations as required and implement corrective action.
- Facilitate incident review process.
- Maintain and update records and systems as required.
- Retrieve supporting documentation and records to facilitate and support query resolution.
- Ensure deviation owner allocation and re-allocation in accordance to priorities.
- Ensure CAPA actions are implemented (deviations, CAPAs, Change controls).

**Process and system improvements**
- Continuously review process impacting manufacturing and release to identify and implement optimization measures to improve efficiency and effectiveness.
- Manage, review and approve change control programs and deviations/ concessions comply to standards and specifications.
- Optimise processes and identify gaps in policies/ procedures.
- Drive CAPA investigations in area of focus.
- Implement and maintain KPIs and trackers supporting business objectives.

**Planning**
- Plan and prioritise own and team daily, weekly and monthly activities.
- Determine, request and use resources/ assets optimally.
- Align activities with business and customer product release priorities.

**Stakeholder management**
- Key interface between production and support departments with main interface being with the QA department.
- Customer interface as needed to share information, feedback on open items, retrieve guidance and facilitate priorities.

**GMP Compliance**
- Facilitate and support audit management.
- Enforce and control area compliance (personnel, documentation, process, product).
- Ensure production process adherence to standards and specifications.
- Enable teams and process to achieve documentation and deviation right first-time targets.

**Skills required**

**Background/experience**
- BPharm Degree
- 1-3 years’ related work experience
- Pharmaceutical manufacturing experience

**Specific job skills**
- Comprehensive knowledge of pharmaceutical manufacturing, standards, and compliance requirements
- Ability to interpret and implement policies, processes, and objectives.

**Competencies**
- Leadership
- Managing complex task and integration of multiple variables
- Interrogating information
- Meeting deadlines
- Finalising output
- Taking action

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