Production Pharmacist

4 months ago

Port Elizabeth, South Africa Aspen Pharma Group Full time

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.

**Planning and Procedures**
- Plan and prioritize 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 authorizations
- 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
- Optimize 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

**Skills Required**:
**Background/experience**
- Minimum of bachelor’s degree preferred, ideally in Pharmacy
- 1-3 years’ related work experience
- Pharmaceutical manufacturing experience
- Registration with Pharmacy Council

**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
- Finalizing output
- Taking action

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