53 Regulatory Inspections Jobs - Page 3

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5.0 - 9.0 years

0 Lacs

hyderabad, telangana

On-site

As the Quality Management Systems (QMS) Manager at our corporate departments, you will play a vital role in ensuring the highest standards of quality across all aspects of our operations. Your responsibilities will include reviewing, approving, and closing change controls, deviations, and incidents for the corporate department. Additionally, you will be tasked with reviewing change controls for oral dosage forms across all Hetero formulations facilities. Your role will also involve reviewing Process Validations, Continued Process Verification, Cleaning Validations, Hold time studies, and Annual Product Quality Reviews (APQR) across our formulations facilities. You will be responsible for coo...

Posted 3 months ago

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5.0 - 8.0 years

15 - 16 Lacs

gurugram

Work from Office

Role & responsibilities 1. Develop and implement an effective compliance program. 2. Review of policies, processes and control systems to ensure compliance with regulatory guidelines. 3. Tracking of new regulations and ensuring implementation in the business with relevant stakeholders. 4. Identify Compliance risks pertaining to the business and Conduct Compliance Risk Assessment. 5. Manage regulatory inspections, audits and ensure timely submission of data. 6. Managing, monitoring and tracking the compliance tool with report out and timely dashboards to the management. 7. Conduct testing of regulatory requirements and the control systems. 8. Any other job assigned by the management. Preferre...

Posted Date not available

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2.0 - 5.0 years

3 - 5 Lacs

vadodara

Work from Office

Company Name: Exemed Pharmaceuticals ( Formulation Business) Designation: Sr. CT QA-Auditor Experience Range: 4-5 years Required Qualification: B. Pharm or M. Pharm (Pharmacology) or Msc in Clinical Research Name of Replacer, Please Specify: New Position Required Skill Set: 1. Must have experience of CT Phase 3 & Phase 4 Audits 2. Ready for travelling 3. Familiar with ICH-GCP guidelines 4. Proficient with MS excel, MS word and Power point 5. Experience with oncology trials is an additional advantage Job Description (Compulsory): 1. Prepare audit agenda, checklist and reports 2. Conduct and oversee audits of investigators site, vendors facilities and systems 3. Review of Site Master File 4. R...

Posted Date not available

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