Job Title: Data Integrity Surveillance Manager
Company Overview:
Naprod Life Sciences Pvt. Ltd. is a rapidly expanding pharmaceutical company dedicated to upholding the highest standards of quality, compliance, and innovation. We are committed to developing and manufacturing life-enhancing products while maintaining robust operational integrity. As we continue to grow, we are strengthening our teams to ensure excellence across all facets of our organization.
About the Opportunity:
We are actively seeking an experienced and highly skilled Data Integrity Surveillance Manager to join our dynamic team in Boisar. This pivotal role is essential for driving our commitment to data accuracy, reliability, and regulatory compliance. The successful candidate will be a proactive leader, critical in establishing and maintaining a stringent data integrity framework, ensuring that all our data management practices adhere to global pharmaceutical standards. If you possess a profound understanding of regulatory requirements and a passion for ensuring data excellence, we invite you to contribute to our mission.
Key Responsibilities:
As the Data Integrity Surveillance Manager, you will be responsible for:
- Leading the strategic implementation and continuous adherence to ALCOA++ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) across all data generation, processing, and archival systems.
- Developing, enhancing, and overseeing comprehensive Data Integrity governance policies, procedures, and frameworks throughout the organization.
- Ensuring meticulous compliance with Computerized System Validation (CSV) requirements for all relevant IT and automated systems used in pharmaceutical operations.
- Proactively preparing the company for internal and external audits by regulatory bodies, ensuring all data integrity aspects meet and exceed audit expectations.
- Conducting regular surveillance, monitoring, and trend analysis of data integrity performance to identify potential risks and implement effective corrective and preventive actions (CAPA).
- Providing expert guidance, mentorship, and training to various departments on data integrity best practices, regulatory expectations, and new compliance standards.
- Collaborating with cross-functional teams to integrate data integrity considerations into new projects and system implementations.
Qualifications:
- Education: A Bachelor’s (B.Pharm) or Master’s (M.Pharm) degree in Pharmacy is essential.
- Experience: A minimum of 10 to 15 years of progressive experience within the pharmaceutical industry, with a substantial focus on Data Integrity, Quality Assurance, Regulatory Affairs, and Computerized System Validation.
- Skills: Demonstrated expertise in global regulatory guidelines (e.g., cGMP, FDA, MHRA), exceptional analytical and problem-solving capabilities, strong leadership presence, excellent communication and interpersonal skills, and a proven track record in driving successful compliance initiatives.
Location:
This full-time position is based at our state-of-the-art facility in Boisar.
Application Process:
If you are a dedicated professional with the requisite experience and a commitment to maintaining the highest standards of data integrity in the pharmaceutical sector, we encourage you to apply. Please submit your comprehensive resume along with a cover letter detailing your qualifications and relevant experience.
