Ensure in-process materials and finished products comply with GMP guidelines, regulation, and in-house SOPs. Determine product release for use into the marketplace, Control of documentation in compliance with regulation and company policies and procedures, and all administrative tasks.
Responsibilities
Planning and project support
- Implement and coordinate systems and procedures and make decisions within policies and procedures, or as authorised by superiors
- Product Release
- Review batch documentation and production conditions to assess compliance to quality procedures, standards and product specifications
- Review and approve quality of new, in-process and released batches to assess compliance to quality control programs, product specifications, and GMP guidelines
- Approve and release production batches
- Execute batch release priorities in line with OTIF and planning schedule
- Ensure release requirements are met for finished products
- Determine disposition of in-process and finished products for clinical and commercial use
- Ensure changes/ deviations in production or quality control have been approved according to QMS
- Initiate tests/ checks/ inspections/ sampling to mitigate any risk associated with planned changes/ deviations
- Ensure production and QC documentation are completed in compliance with SOPs
- Monitor and audit compliance to regulatory and in-house standards with regards to current GMP
- Report observed deficiencies in process and follow up on corrective action
- Investigate systematic quality problems and develop preventative plans, in conjunction with Production
- Provide input into GMP-related
Reporting
- Complete and consolidate standard documents
- File, archive and retrieve documents
- Maintain and update records and systems as required
- 2 – 4 years’ experience in pharmaceutical product release and planning processes
- Bachelor’s degree in Pharmacy
Specific job skills
- Comprehensive knowledge of pharmaceutical manufacturing and corrective action programs
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives
Competencies
- Information Gathering
- Interrogating Information
- Meeting Deadlines
- Finalising Output
- Taking Action
Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CVs online on or before the specified date. Preference will be given to applicants from designated groups, through a fair recruitment and selection process, in accordance with laws governing employment equity, where such laws are applicable to the Aspen entity that will employ the successful candidate.
Only short-listed candidates will be contacted, thus if you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.
Internal Applicants must inform their direct line managers of their application. Applications must be completed using an Aspen email address.