QA Specialist (Validation)

KEY DUTIES AND RESPONSIBILITIES:

1. Preparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines.

2. Execution of qualification and validation activities including process, cleaning, computer system, equipment, utilities, and facility.

3. Candidate must have knowledge and experience of qualification/validation principles and their practical application.

4. Preparation and review of process and cleaning validation protocols and reports.

5. Coordinate with the cross functional team and external service provider to meet qualification & validation schedules and maintain equipment, systems, and processes in validated state.

6. Review equipment and process related change control; perform Risk Assessment to determine criticality of the proposed changes.

7. Write, review, and revise validation SOPs in compliance with regulatory guidelines.

8. QA oversight and/or review during the validation process.

9. Manage incidents and deviations related to validation & qualification.

10. Perform compliance reviews of all applicable deviations, investigations, and CAPAs related to qualification and validation.

11. Review and suggest continuous improvements to the Validation Master Plan, current quality system practices, validation protocols and procedures for newly installed equipment, and overall validation strategies.

12. Cross train and develop expertise in other areas of validation.

13. Must be able to interact and lead effectively in a team-based environment.

14. Familiarity with regulatory/compliance environment.

EDUCATION & EXPERIENCE:

1. Degree in a scientific discipline or equivalent.

2. Experience in a regulated industry preferred.

3. Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer.

4. A minimum of 5-7 years’ relevant experience in pharmaceutical manufacturing environment.

Candidates are encouraged to apply for this position via email to Phghr@pharmagend.com with the following information in the resume:

Work experiences and job responsibilities.
Current and Expected salary.
Reason for leaving.
Date of availability.
Education background.

We regret that only shortlisted candidates will be contacted.