Production Pharmacist

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 & 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 & 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 & 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.

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.