Regulatory Compliance Officer
- Full time
- Part time
- One time
Gachibowli, Hyderbad Executive Corporate
Indian Immunologicals Limited
From August 2006
Key Deliverables based on Current job Roles:
• Change management for all Analytical, Qualification and Packaging related that is Initiation and review for all changes.
• Change management design and life cycle routing creation and flow charts preparation
• Process non-conformance initiation and initial review for all quality related and non-quality related non conformances.
• Perform and complete investigations for minor, major and recurring cases in a standardized process as per QMS..
• To execute change control activities upto annual notification to regulatory authorities according to the global Change Control process.
• To prepare and publish the Change Control Reports.
• Ensure closure of change controls and data consistency and QMS compliances.
• Supporting to the Internal audit tire - III audits
• Supporting to the corporate complaints team. Support all activities related to Complaint handling process within External Supply. Ensuring compliance according to the internal quality standards, relevant regulatory requirements and the filed product quality standards.
• Support weekly, monthly, quarterly, annual tracking related to complaints within External Supply (all regions), including reporting of overdue items and trending.
• Report to QA heads to ensure compliance of process.
To manage Change Control process of Cat I changes according to the global SOP.
• Modification of Quality Processes and Audits and Product Approval Systems.
• Handling of complaints and issues related to the products manufactured at the respective Third Parties.
• Successful implementation of Customer Complaints in case of Cold chain Failures
• Development of a coordinated system for the effective handling of Product Standards.
• Quarterly Business Review to monitor KPIs on a regular basis.
• Introduction of Training Tool across the organisation.
• Modification and Customization of Compliance Certificate Processing.
Key Deliverables based on past job...
Qualifications & Certifications
(Biotechnology) Department of Biotechnology in Barkattullah university Bhopal
Sarojini Naidu College
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