Executive - Manufacturing, Science & Technology MS&T (Cleaning Validation)

Job Summary

The Deputy Manager MS&T (Cleaning Validation) is responsible for overseeing all cleaning validation activities in compliance with GMP, SOPs, and global regulatory guidelines (Health Canada, FDA, EU). The role includes supervision, training, and development of personnel involved in validation protocol execution and report preparation, with accountability for work scheduling, project prioritization, and timely resolution of roadblocks.

The position ensures strategic implementation of the Cleaning Validation program, conducts technical risk assessments, supports deviation investigations, and drives effective CAPAs. As the department SME for cleaning validation, the Deputy Manager provides technical leadership, facilitates training, and promotes continuous compliance and operational excellence.

Job Responsibilities

1. Prepare, review, and update standard operating procedures and Validation Master Plan.
2. Responsible for preparation, review and updating of VMP, CVMP (cleaning validation master plan), PVMP (process validation master plan) and SOP related to cleaning / process validation.
3. Coordinate and review quality risk management (QRM).
4. Prepare and review cleaning validation protocols and reports. Perform cleaning validation product risk assessments to identify worst-case molecules for cleaning validation.
5. Responsible for cleaning validation activities in compliance with the various guidelines / standards and to monitor the regular cleaning monitoring activities, to be in line with the schedule and escalating the deviations to superiors.
6. Cleaning validation related activiteds and e-Residue software application activities.
7. Responsible for preparation and review of cleaning validation matrix.
8. Responsible for preparation and review of PDE change.
9. Responsible for preparation and review of cleaning validation protocols and reports.
10. Responsible for Quarterly/Annual monitoring report for cleaning validation.
11. Prepare and review of quarterly and annual monitoring reports for cleaning validation.
12. Prepare for regulatory audits and ensure compliance.
13. Prepare and review process validation in QMS Trackwise & PACE.
14. Conduct assessments for change control, action items, and review MDoc from various departments in QMS Trackwise.Support regulatory and internal inspections, prepare departmental reports (monthly/annual), and present status updates to management.
15. Foster a high?performance culture aligned with organizational values (Integrity, Courage, Teamwork, Innovation) and ensure adherence to all compliance and HR programs.
16. Serve as the primary liaison for validation projects, ensuring customer needs, timelines, and priorities are consistently met.
17. Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development
18. Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Integrity, Courage, Teamwork, Innovation
19. Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process
20. All other duties as assigned

Job Requirements

• Education:
  • Minimum Master Degree in Pharmacy or Science

• Knowledge, skills and abilities            :
  • Should have knowledge of process development and Technology transfer on Solid dosage forms for regulated markets like USA, Europe, Canada and Australia is essential.
  • Should have a good understanding of Product development process along with scale-up knowledge of the product and Process Validation.
  • Should have good understanding of clinical and regulatory requirements of USA, Canada, Australia, and European regulatory agencies.
  • Should have good communication and interpersonal skills along with Computer efficacy in MS-Office and Internet
  • Possesses/develops the ability to adapt to frequent changes in priorities and schedules.
  • The willingness to upgrade knowledge/education on an on-going basis.

• Experience
  • Minimum 2 to 5 years of Experience in Cleaning Validation and exposure to Cross Contamination control  of the Pharmaceutical product in GMP Regulated Industry.