Job Description

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

ResponsibilitiesStaff 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.

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 requiredBackground/experience

• Minimum of Bachelors 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

Aspen Pharmacare