Validations Analyst
Applied Sciences, Aviation Jobs
- Plus Five Pharmaceuticals
- Expires 22 Oct 2021
- Bulawayo
- Full Time
Job Description
The Validation Chemist is responsible to the Validations Manager and will focus on:
1. Qualification of facilities, utilities and equipment.
2. Validation of processes, cleaning validation, computer validation and analytical method validation.
3. Carrying out APQR, cross contamination studies and Hold time studies
4. Carrying out of risk and impact assessment on systems and on any proposed changes to validated systems.
5. Writing of SOPs, validation protocols and reports of validation efforts. Carrying out training on validation.
Duties and Responsibilities
1 Contribute to regeneration, review and maintenance of the validation master plan.
2 Write and review validation/revalidation plans
3 Initiate, prioritize and schedule validation projects in close liaison with Validations Manager
4 Write and review validation protocols, validation reports, changes and deviations procedures and investigations for both existing and products under development.
5 Co-ordinate and/or perform sampling operations as required by the protocols stated above.
6 Carry out and document risk assessment and impact assessment for all validation efforts comprising qualification of facilities, utilities and equipment, process validation, cleaning validation and Analytical Method Validations.
7 Participate in procurement of new equipment, utilities in context of input in user requirement specifications (URs) and qualifications.
8 Plan and co-ordinate validation activities that require input from production, maintenance, QA/QC, purchasing and other departments.
9 Investigate any deviations from validation protocols, identify root cause of the non-conformity or irregularity, and carryout corrective and preventive actions and follow-ups.
10 Develop and review of validation SOPs.
11 Participate in technology transfer of new products by Research & Development to manufacturing.
12 Participate in technology transfer of new products being developed via the dossier purchase.
13 Participate in internal and external quality audit programmes to assure compliance to cGMPs in particular internal quality audits of the core production areas and key inspections by MCAZ, WHO e.t.c.
14 Address and follow up on any issues or corrective actions generated from Quality audits.
15 Identify and assist in the resolution of quality related issues that impact on cGMP compliance or other risks to company products, such as customer complaints resolution and product/process challenges, changes and deviations, and the appropriate trending.
16 Plan, co-ordinate regular or rolling Product Quality Review (PQR) and ensure that reports for each product manufactured in a given year are done.
17 Supervise, allocating specific jobs, training and appraising subordinates.
Train personnel on validation issues regularly.
18 Maintain control of the various documentation related to validation activities.
19 Maintain current knowledge of regulatory standards, which govern the development, and manufacturing of pharmaceuticals in the various markets served by the company.
20 Maintain an up to date knowledge of technical and cGMPs as it pertains to the position's responsibilities.
21 Report monthly on activities to the Validations Manager
22 Perform other duties as assigned by the Validations Manager
Qualifications and Experience
• BSc Applied Chemistry or Chemical Technology.
• Good knowledge of the current Good Manufacturing Practices
• Very good knowledge of Good Laboratory Practices
• Knowledge of pharmaceutical analysis
• Knowledge of validation
• Reliability and Innovativeness
• Teamwork and Organizational Skills
How to Apply
Interested and qualified candidates to send their CVs to mercyn@plusfivepharma.com copying petronellak@plusfivepharma.com not later than 22 October 2021
