Validation Officer

Start date: Candidate must begin working within a reasonable period.

Roles and Responsibilities

1. Responsible for preparation and review of protocols and reports for process validation.
2. Responsible for execution of process validation activities in OSD manufacturing.
3. The complete knowledge of the manufacturing process along with BMR/BPR execution.
4. The complete knowledge and understanding of process capability report like Pp, Ppk, Cp, Cpk, CPU, PPU, St.Deviation CPL etc.
5. Tracking of process validation activities as per the site Validation Master Plan and ensure that they are implemented as per schedule.
6. Responsible for development and implementation of procedures and instructions applicable to process Validation activities.
7. Responsible for the retention and control of validation related documentation at the facility.
8. Initiate and participate in change control management and assess impact on validated processes.
9. Hand-on experience of handling Deviation, Investigation and other QMS related to manufacturing process.
10. The competent on the regulatory and process requirement for the new product manufacturing along with co-ordination of CFT departments.
11. Implement Continued process verification (CPV) by monitoring process validation and annual monitoring strategies that ensure that all critical process parameters and quality attributes are monitored or analysed, and actions taken in case of trends or deviations.
12. Participate in risk management activities applicable to process validation.
13. Prepare protocols, execute and prepare reports for cleaning method validation activities.
14. Participate in product investigation for validation related matters and implement corrective and preventive actions.
15. Participate in audits and inspection and ensure inspection readiness for the site.
16. Prepare protocols, execute and prepare reports for Hold time studies.

Qualifications

• Bachelor’s degree in chemistry, pharmacy, pharmaceutical sciences, chemical engineering

Experience

• 3-4 years of practical experience in OSD pharmaceutical manufacturing operations or hands on experience in validation activities.

Equal Opportunities Employer: Dei Biopharma Ltd. provides equal opportunity and fair and equitable treatment in employment to all people without regard to race, color, religion, sex, national origin, age, disability, political affiliation, marital status, or sexual orientation.

How to Apply: All interested candidates who meet the required qualifications and experience are invited to submit their CVs, Cover Letter & Academic documents (addressed to the Head of Human Capital)

All Application documents should be merged as one document in PDF or .DOC / .DOCX, which should not exceed 10MB

Applications should be sent by email to recruitment@deibiopharma.com with the job title in the subject line.

Should you not hear from us within fourteen (14) days from the closing date of this advertisement, you may consider your application to be unsuccessful.