Research and Development Chemist
Applied Sciences, Aviation Jobs
- Plus Five Pharmaceuticals
- Expires 27 Aug 2020
- Bulawayo
- Full Time
Job Description
i. Carry out full analytical method development, analysis of all starting, in-process and finished product materials used in product development in compliance with either BP/USP/EP/IP after receipt.
ii. Ensure compliance with regulatory requirements, ICH (International Committee on Harmonization) , MCAZ, EMA, Health Canada , US FDA and WHO TRS guidelines and schedules set up by the HOD (Head of Department) .
iii. Ensuring strict observance of CGMP , GDP and CGLP in all activities.
iv. Arranging for outsourced activities, sourcing analytical reagents and equipment as might be needed for Research and development.
v. Special projects as needed and any other tasks assigned by the Head of R&D.
Duties and Responsibilities
1. Analysis of all starting materials used in the research and development department within reasonable period of receipt of the material.
2. Real time and accelerated stability studies of samples in accordance with stability schedules and SOP’s
3. Writing up of documentation for CTD , documentation compilation
4. Investigations and compatibility studies of drug substance and excipient in line with ICH standards and regulatory requirements.
5. Analytical method development and method validation
6. Analysis of samples under pharmaceutical development.
7. Raw material characterization for critical quality attributes.
8. Bio-waiver studies in compliance with regulatory requirements.
9. Generating adequate documentation and reports for the work undertaken including completion of notebooks.
10. Provides technical knowledge in guiding other formulators, assistants and technicians in the R&D Lab
11. Qualification of suppliers of starting materials for developmental needs
12. Analytical Method development and validations (qualitative and quantitative methods)
13. Establishing in-house systems and procedures to ensure cGMP, and cGLP practices & regulatory requirements
14. Development of specifications for starting materials i.e. raw materials and packaging materials.
15. Analysis of samples under pharmaceutical development studies.
16. Development and setting of in-process specifications for products under development.
17. Planning logically analysis, and Research and development activities
18. Development and setting of specifications for finished products under development.
19. Development of formulations for non-pharmaceutical products under development.
20. Formulation development for pharmaceutical products.
21. Routine formulation studies for commercial batches facing quality and manufacturing challenges.
22. Cleaning method development and validations.
23. Dissolution method development and validation
24. Packaging material development and specifications
25. Container closure system and drug substance stability and compatibility studies
26. Photostability studies
27. Registration dossier compilations
28. Writing of Standard Operating Procedures
29. Ensure Timeous release of analytical Results and Reports
30. Completion of notebooks and checking of subordinate’s notebooks
31. Formulations investigations of commercial batches
32. Qualification and calibrations of R&D’s measuring and analytical equipment or instruments
Qualifications and Experience
• Bachelor of Science Degree in either Chemistry, Biochemistry, Microbiology, Chemical Engineering and/or Applied Chemistry and Biochemistry
• Very good knowledge and several years experience in the area of pharmaceutical instrumental analytics, microbiological and chemical testing procedures
• Good knowledge of current Good Manufacturing Practices standards and guidelines adopted by the following regulatory MCAZ, MCC (South Africa); WHO (World Health Organization); EU (European Union) and FDA (USA).
• Good knowledge of Common technical Documents , CTD , International Common Harmonization (ICH ) , Food and drug administration (FDA) , Japanese Cannadian medicines agencies , ZAZIBONA ( SADAC Common Registration initiative), Scaleup- and Post approval changes ( SUPAC)
• Very good knowledge of Medicines Control Authority of Zimbabwe’s (MCAZ) regulations.
• Very good knowledge of Good Laboratory Practices.
• Very good knowledge of ICH (international Committee of Harmonization) guidelines.
