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