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Manager

Pfizer


Location:
Aurangabad, MH 431006
Date:
01/06/2018
2018-01-062018-02-06
Pfizer
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Job Details

B.Pharm or M.Pharm/M.S.C, with specialization in Pharmaceutics or Industrial Pharmacy and having min. 10-16 yrs. of experience.







+ Well experienced on GMP and GLP activity and to perform and review data integrity risk assessment and process design to assure data quality and integrity



+ Review computer system operation and validation documents for Data Integrity prospective.



+ Provide technical expertise to plant / quality management which defines and implements an effective Data integrity system compliant with the CFR's and meets the business needs of the organization.



+ Gap Assessment of systems, procedures, practices to avoid data integrity issues.



+ Participation in training on Data Integrity, Good Documentation Practices and helping the colleagues to be in compliance by continuous tracking and interactions.



+ Updation to the team in terms of regulatory expectations related to Data Integrity and Good Documentation Practices.



+ Discussing with the team related to recent regulatory findings for Data Integrity and Good Documentation Practices.



+ Review of Audit trial and system generated electronic records







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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