Compliance Pharmacist (Port Elizabeth) at Aspen Pharma Group

Job purpose

• Review and approve quality related activities for value streams.
• Identify and provide solutions to systematic issues – risk assessments and reviews.
• Monitor 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.
• Warehouse 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 analysed 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 prioritize.
• 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.
• Optimize 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.
• Serve as Deputy RP at Aspen distribution centre.

Requirements

Background/Experience:

• Bachelor’s degree (B.Pharm) with 3-5 years related warehouse or logistics work experience.
• Pharmaceutical manufacturing or dispensing experience.

Specific job skills

• Advanced understanding of the pharmaceutical manufacturing and corrective action programs
• Pharmaceutical 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
• Offering insights
• Taking action