Compliance Pharmacist

3 months ago

Port Elizabeth, South Africa Aspen Pharma Group Full time

**Overview**
- Review and approve quality related activities for value streams
- Identify and provide solutions to systematic issues - Risk assessments and reviews
- Monitor manufacturing compliance to GMP and statutory requirements and internal warehouse audits
- Monitor adherence to guidelines, procedures and document controls
- Deliver expected value stream targets as per business requirements
- Warehouses GMP compliance
- Team and process development

**Responsibilities**

**Staff development**
- Facilitating training sessions as required related to improvements and CAPA’s
- Train Warehouse Pharmacist and PMAs on SOPs in transition periods - improvements of systems
- And stand-in when needed within the warehouses.

**Planning and Process**
- Provide technical and operational input during drafting of plans and procedures specific to Unit

**Process Compliance**
- Execute day-to-day quality activities for value streams related to department
- Identify systematic technical and process issues by reviewing CAPA requests and trends
- Develop CAPA plans and change incidents to address process compliance within the department
- Implement operational changes to SOPs and processes, in compliance with control processes
- Ensure deviations(planned/unplanned) and concessions are documented, reviewed, and analyzed and recommend validation activities to be performed
- Execute change control process by ensuring changes are documented, reviewed and approved.
- Ensure process compliance up to date in all departments and drive close out of these.

**In-process Quality Management**
- Review and approve outcome of in-process internal inspections

**Product release management**
- Deviation management and adherence to daily, weekly targets
- Review and approve deviations, assist in investigations as required and implement corrective actions
- Maintain and update records and systems as required
- Ensure deviation owner allocation and re-allocation in accordance to prioritise
- Ensure CAPA actions are implemented (deviations, CAPAs, Change Controls)

**Process and System improvements**
- Manage, review, and approve change control programs and deviations/concessions comply to standards and specifications
- Optimise processes and identify gaps in procedures
- Drive CAPA investigations in areas of focus
- Initiate formal and informal RA (Risk Assessments) for quality related topics for new processes

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

**Customer Relations**
- Important communication required with external customers regarding quality expectations of a product
- Implementing quality protocols which aligns with the customer

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

**Skills required**

**Background/experience**
- Minimum of Bachelor’s degree (B Pharm)
- Knowledge of regulatory guidelines, warehouse and distribution requirements
- Minimum 3-5 years related work experience in logistics
- Pharmaceutical manufacturing or dispensing experience
- QMS experience
- Regulatory audit experience or internal audit experience

**Specific job skills**
- Knowledge of pharmaceutical manufacturing and distribution and corrective action programmes
- Pharmaceutical standards and compliance requirements
- Report writing skills
- Ability to interpret and implement policies, processes and objectives

**Competencies**
- Offering Insights
- Leadership
- Taking Action
- Managing complex tasks and integration of multiple variables

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