Production Pharmacist

1 week ago

Port Elizabeth, South Africa Aspen Pharma Group Full time

**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.

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