Associate Manager
Job Description
Department DetailsCQARole SummaryData Integrity - Compliance OfficerKey ResponsibilitiesResponsibility
1. Ensure overall compliance to GxP requirements and data integrity point of view at site (Injectable and OSD).
2. Ensure the documentation practices followed at site as per cGMP and ALCOA+ principles.
3. Conduct the training on good documentation practices and data integrity and creation of awareness with respect to data integrity.
4. Perform the online review at shop floor for good documentation practices.
5. Prepare the schedule and perform the data integrity audits as per site specific procedure.
6. Communicate observed discrepancies to compliance and QA head and perform the investigations for observed discrepancies and establish the CAPA.
7. Perform the audit trials and ensure the compliance with respect 21 CFR part 11.
8. Responsible for all compliance and bringing solutions to compliance related issues within the site.
9. Perform the Gap assessment with respect to regulatory guidelines (USFD/EU/ANVISA) and ensure its compliance.
10. Review existing SOP, Process, and good documentation practices to strengthen controls.Educational QualificationsRequired Education Qualification: M.Pharma
Required Experience: 8 - 12 years
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Job Detail
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Job IdJD3439137
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationIndia, India
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EducationNot mentioned
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ExperienceYear