- 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
Staff development
- Facilitating training sessions as required related to improvements and CAPAs.
- Train Warehouse Pharmacist and PMAs on SOPs in transition periods - improvements of systems
- And stand-in when needed within the warehouses.
- Provide technical and operational input during drafting of plans and procedures specific to Unit
- 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.
- Review and approve outcome of in-process internal inspections.
- 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)
- 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.
- 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.
- Important communication required with external customers regarding quality expectations of a product.
- Implementing quality protocols which aligns with the customer.
- 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.
- Bachelors degree (B.Pharm) with 3-5 years related warehouse or logistics work experience.
- Pharmaceutical manufacturing or dispensing experience.
- Advanced understanding of the pharmaceutical manufacturing and corrective action programs
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives.
- Leadership
- Managing complex task and integration of multiple variables
- Interrogating information
- Offering insights
- Taking action
