Production Pharmacist (Fixed term contract)
Aspen Pharma Group
2023-07-30 Port Elizabeth
Job Ref #: AP-4273
Industry: Manufacturing
Job Type: Contract
Positions Available: 1
Applications are invited for the above indicated vacancy that exists in OSD department. The successful incumbent will report to the Compliance Pharmacist. Preference will be given to Employment Equity candidates in line with Aspen’s Transformation Agenda.
Job Description
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
Job Requirements
Skills Required
Background/experience
BPharm Degree 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 Interrogation Information Meeting deadlines Finalising output Taking action
No CV Required
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