Position : Pharmaceutical Manufacturing Technologist
Salary : Market Related & negotiable
Location : Port Elizabeth
Send detailed CV in Word Document, copy of Id, head and shoulders photo of yourself, pay slip, plus Qualifications urgently to speed up your application!!!!!!
Applicants are invited to apply for this excellent opportunity that exists for the above mentioned position. The successful incumbent will report to the Manufacturing SME.
We encourage you to apply for the above which will be ring-fenced for employees who have been mapped to this role only according to skills retention criteria.
Kindly be advised that only permanent employees are eligible to apply.
Provide technical / scientific support for internal and external technology transfer of manufacturing processes. Implement process validation activities and post-transfer support.
Trouble shoot problems encountered during tech transfer / process optimization / commercial manufacture and supports continuous improvement.
Planning and project support
Research and report on solutions to improve tracking, planning and collaboration
New product introduction assessment
Technical evaluation of products and processes
Draft transfer protocols, project plans and timelines and prepare proposals and status reports
Compile technical documents that comply with local and international regulatory guidelines
Support technology transfer team activities and projects
Identify project issues and recommend methods for resolution
Manage aspects of tech transfer projects, including :
Feasibility and risk assessment
Trial and validation batch manufacturing
Execution and tracking
Manufacturing science, technology troubleshooting
Provide planned and unplanned production support
Troubleshoot process / product problems
Guide during process changes, process optimization including API / IPI source changes
Provide manufacturing science & technical support for deviations, CAPA"s, OOSs and technical complaints
Risk management and process validation
Conduct feasibility and risk assessments
Ensure that project planning encompasses quality, risk and process validation aspects
Ensure regulatory compliance throughout tech transfer processes
Support investigations associated with tech transfer activities
Carry out Process Qualification (PQ) and Continued Process Verification (CPV) activities to validate transferred processes
Background / experience
4 to 6 years experience in technical transfer , with two years in a pharmaceutical manufacturing environment, or one to two years experience in relevant manufacturing environment
Bachelors degree in Pharmacy, Engineering or similar
Specific job skills
Knowledge of Pharmaceutical technical issues, manufacturing processes and operations environment
Knowledge of validation, regulatory affairs, R&D, and new product transfer
Knowledge of local and international pharma guidelines
Technical / scientific report writing