Manufacturing, Science & Technology Executive
Apotex Research Pvt. Ltd · Bengaluru · onsite · Posted 70d ago
Undisclosed2–6 yrsfulltimeSourced from
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About this role
Job Summary
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
The Deputy Manager MST (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 - Prepare, review, and update standard operating procedures and Validation Master Plan.
- 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.
- Coordinate and review quality risk management (QRM).
- Prepare and review cleaning validation protocols and reports. Perform cleaning validation product risk assessments to identify worst-case molecules for cleaning validation.
- 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.
- Cleaning validation related activiteds and e-Residue software application activities.
- Responsible for preparation and review of cleaning validation matrix.
- Responsible for preparation and review of PDE change.
- Responsible for preparation and review of cleaning validation protocols and reports.
- Responsible for Quarterly/Annual monitoring report for cleaning validation.
- Prepare and review of quarterly and annual monitoring reports for cleaning validation.
- Prepare for regulatory audits and ensure compliance.
- Prepare and review process validation in QMS Trackwise PACE.
- 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.
- Foster a highperformance culture aligned with organizational values (Integrity, Courage, Teamwork, Innovation) and ensure adherence to all compliance and HR programs.
- Serve as the primary liaison for validation projects, ensuring customer needs, timelines, and priorities are consistently met.
- 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
- 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
- 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
- All other duties as assigned
- 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.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
process validationcleaning validationpharmaceuticalsacquisitionsEmployee developmentauditsChange Controlprocess developmentPharmacyManufacturingcompliancePharmaceuticalCommunication And Interpersonal Skills
About Apotex Research
Apotex Research Pvt. Ltd
Pharma
1.2k+
employees
2003
23 years old
Bangalore / Bengaluru, Karnataka
India
₹9L PA avg
Avg at Apotex Research
About
We improve everyday access to affordable, innovative medicines and health products for patients and consumers worldwide.
Industries
PharmaAnalytics & KPO
Employee ratings
10 reviews
3.8/ 5
Culture
4.0
Career growth
3.5
Work-life
3.7
Employees rate it well for
Work-Life Balance38Overall Company38
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