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3.0 - 7.0 years
0 Lacs
hosur, tamil nadu
On-site
You are a dedicated and detail-oriented Data Integrity (DI) Specialist joining our Quality Assurance and Compliance team. Your main responsibility is to ensure that all data generated and maintained across the site meets regulatory, quality, and organizational standards. Your role is critical in fostering a culture of data integrity by adhering to ALCOA++ principles and implementing comprehensive data governance practices. Your tasks include ensuring Data Integrity is followed across the site, verifying that all data align with ALCOA++ principles, creating and maintaining documentation on data policies, and ensuring compliance with data regulations and security standards. You will also be responsible for monitoring access to sensitive data, installing protective measures for Data Integrity, and ensuring that only authorized personnel can access protected information. Additionally, you will play a key role in ensuring the company's computer system data are safely maintained, overseeing employees" adherence to Data Integrity assurance standards, and promoting a culture of Data Integrity assurance across the site. You will work closely with the remediation team to ensure that Data Integrity assurance practices are followed by all employees. Qualification requirement for this role is MSc in Chemistry or B Pharma. Key skills required for this position include knowledge of data regulations, quality assurance principles, monitoring access to data, implementing protective measures, maintaining documentation, understanding ALCOA++ principles, data security protocols, data integrity practices, data governance principles, QC instrumentation, compliance standards, and computerized system validation (CSV).,
Posted 1 week ago
4.0 - 6.0 years
4 - 6 Lacs
Jammu
Work from Office
Role & responsibilities Job Responsibilities knowledge on Quality control function like FP/RM/PM/Stability of Solid dosage forms. good knowledge on QC Instrumentations trouble shooting of QC instruments like Auto titrator, HPLC, GC etc. 21CFR part 11 compliance and Computer system validation Investigation like OOS, OOT, events and deviation management. LEAN management and Good presentation skill exposure to Regulatory Audit handling and management review of SOPs versus practices for gap analysis. Trending of QC data and deriving action plan for compliance readiness Preferred candidate profile B.Pharma / M.Sc with 4 to 6 yrs experience as QC investigator. good in english verbal and written communication, ready to relocate to Jammu Location.
Posted 1 month ago
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