Production Pharmacist

7 days ago


East London, Eastern Cape, South Africa Aspen Pharma Group Full time
Job title : Production Pharmacist (East London)Job Location : Eastern Cape, East LondonDeadline : April 13, 2025Quick Recommended Links
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Description
Overview

  • Monitor manufacturing compliance to GMP and statutory requirements
  • Monitor adherence to guidelines, procedures and document controls
  • Deliver expected productivity targets as per business requirements
  • Related administrative tasks
  • Serve as back up to Team Leader on shift

Responsibilities

Planning and Procedures

  • Plan and prioritise daily, weekly and monthly activities
  • Determine, request and use resources/ assets optimally

Inspections and Verifications

  • Verify schedule 5 products
  • Verify certified clean status of rooms and equipment
  • Verify, review and approve verification of measuring equipment performance, calibrations and sampling, and dispensing of materials

Line and Production Processing

  • Perform, review and approve line sign-on's, closures and clearance authorisations
  • Perform, review and approve batch reconciliations to product specifications and quality
  • Ensure production process adherence to standards and specifications

Process and System Improvements

  • Manage, review and approve change control programs and deviations/ concessions comply to standards and specifications
  • Manage and resolve customer complaints
  • Optimise processes and identify gaps in policies/ procedures
  • Drive CAPA investigations in area of focus

Compliance and Auditing

  • Perform and review shift GMP checks, environmental checks, and agent expiry dates, and ensure continued compliance
  • Verify good document practice as per SOP and regulation
  • Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
  • Verify IPCs are in line with product quality and specifications
  • Review and approve preliminary batch records
  • Audit logbooks and systems

Troubleshooting

  • Investigate deviations and concessions, and assess risk
  • Raise deviations and implement corrective action
  • Raise maintenance notifications as and when required 

Training and Technical Expertise

  • Train new Pharmacists and PMAs on SOPs in transition period
  • Identify refresher or awareness training needs

Administration and Record Keeping

  • Complete batch records and labels
  • Complete deviation forms as required
  • Query documents and sign off declarations
  • Perform and verify calculations in BMR
  • Maintain and update records and systems as required
  • Retrieve supporting documentation and records to facilitate and support query resolution

Requirements
Skills Required

Background/experience

  • BPharm Degree
  • 1-3 years' related work experience
  • Pharmaceutical manufacturing experience

Specific job skills

  • Comprehensive knowledge of pharmaceutical manufacturing, standards and compliance requirements
  • Ability to interpret and implement policies, processes and objectives

Competencies

  • Information gathering
  • Interrogating information
  • Meeting deadlines
  • Finalising output
  • Taking action
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