Production Pharmacist

Aspen Pharma Group; Gqeberha; On-site; ZAR 300 000 - 450 000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a qualified Pharmacist to ensure compliance with GMP standards and optimize manufacturing processes. The role involves monitoring production, conducting inspections, and training staff. Ideal candidates will have a BPharm degree and relevant experience in pharmaceutical manufacturing.

Qualifications

• 1-3 years of related work experience.
• Pharmaceutical manufacturing experience.

Responsibilities

• Monitor manufacturing compliance to GMP and statutory requirements.
• Perform, review, and approve batch reconciliations to product specifications.
• Train new Pharmacists and PMAs on SOPs during transition periods.

Skills

Information gathering

Interrogating information

Meeting deadlines

Finalizing output

Taking action

Education

BPharm Degree

Job description

Job Responsibilities

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

Planning and Procedures

• Plan and prioritize daily, weekly, and monthly activities
• Determine, request, and utilize resources and 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, sampling, and dispensing of materials

Line & Production Processing

• Perform, review, and approve line sign-ons, closures, and clearance authorizations
• Perform, review, and approve batch reconciliations to product specifications and quality standards
• Ensure production process adherence to standards and specifications

Process and System Improvements

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

Compliance & Auditing

• Perform and review shift GMP checks, environmental checks, agent expiry dates, and ensure continued compliance
• Verify good document practice as per SOP and regulations
• Verify the identity of bulk products and printed packaging materials, and conduct intermix checks for 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 risks
• Raise deviations and implement corrective actions
• Raise maintenance notifications as required

Training and Technical Expertise

• Train new Pharmacists and PMAs on SOPs during transition periods
• 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 needed
• Retrieve supporting documentation and records to facilitate query resolution

Background/Experience & Skills

• BPharm Degree
• 1-3 years of 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

Core Competencies

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