Job Description:
The job description is as below:
Perform and oversee audits (facility-based process-based and study-based) as per OECD GLP guidelines.
Review and verify raw data reports and study plans for compliance with applicable GLP standards.
Ensure that standard operating procedures (SOPs) are current and being followed across departments.
Monitor the conduct of pharmacology toxicology and analytical studies to ensure regulatory compliance.
Participate in regulatory inspections and ensure laboratory preparedness.
Maintain audit schedules documentation and deviation tracking systems.
Provide training and guidance on GLP compliance and QAU processes to laboratory personnel.
Support in drafting Quality Assurance Statements and internal audit reports.
Skills and Competencies:
Strong understanding of OECD GLP principles and regulatory requirements.
Hands-on experience with auditing techniques and documentation review.
Good communication and interpersonal skills.
High attention to detail and analytical thinking.
Ability to work independently and as part of a cross-functional team.
Preferred Experience:
Prior experience in QAU department in GLP environment.
Exposure to regulatory audits (e.g. OECD NABL FDA AAALAC etc.).
Experience with digital data systems and QA documentation tools.
Note :- Agreement: 2-year bond and 3-months notice periodSecurity Deposit: Cheque equivalent to 3 months salary to be submitted at the time of joiningIf any employee absconds or leaves without serving the required notice period the company reserves the right to take legal action.
For further details call Megha on or you can mail your candidature on
Required Experience:
Manager
Job Description:The job description is as below: Perform and oversee audits (facility-based process-based and study-based) as per OECD GLP guidelines. Review and verify raw data reports and study plans for compliance with applicable GLP standards. Ensure that standard operating procedures (SOPs) are...
Job Description:
The job description is as below:
Perform and oversee audits (facility-based process-based and study-based) as per OECD GLP guidelines.
Review and verify raw data reports and study plans for compliance with applicable GLP standards.
Ensure that standard operating procedures (SOPs) are current and being followed across departments.
Monitor the conduct of pharmacology toxicology and analytical studies to ensure regulatory compliance.
Participate in regulatory inspections and ensure laboratory preparedness.
Maintain audit schedules documentation and deviation tracking systems.
Provide training and guidance on GLP compliance and QAU processes to laboratory personnel.
Support in drafting Quality Assurance Statements and internal audit reports.
Skills and Competencies:
Strong understanding of OECD GLP principles and regulatory requirements.
Hands-on experience with auditing techniques and documentation review.
Good communication and interpersonal skills.
High attention to detail and analytical thinking.
Ability to work independently and as part of a cross-functional team.
Preferred Experience:
Prior experience in QAU department in GLP environment.
Exposure to regulatory audits (e.g. OECD NABL FDA AAALAC etc.).
Experience with digital data systems and QA documentation tools.
Note :- Agreement: 2-year bond and 3-months notice periodSecurity Deposit: Cheque equivalent to 3 months salary to be submitted at the time of joiningIf any employee absconds or leaves without serving the required notice period the company reserves the right to take legal action.
For further details call Megha on or you can mail your candidature on
Required Experience:
Manager
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