Compliance Pharmacist Warehouse

Port Elizabeth, Eastern Cape, South Africa

Job Description


Overview

  • Review and approve quality related activities for value streams
  • Identify and provide solutions to systematic issues xe2x80x93 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 CAPAxe2x80x99s
  • 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 Bachelorxe2x80x99s 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

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Job Detail

  • Job Id
    JD1351912
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Port Elizabeth, Eastern Cape, South Africa
  • Education
    Not mentioned