
Regulatory Affairs Executive
2 weeks ago
Job Summary:
- Ensure manufacturing process complies with standards.
- Establish and update quality plans.
- Establish and update quality assurance procedures and specifications.
- Maintain and update quality assurance records.
- Data analysis and continual improvement Complaints handling
- Lead or participate in the investigation root cause determination of internal and external
- complaints.
- Initiate and implement corrective and preventive action.
- Document the complaint investigation, CAPA and closure of complaints.
- Direct and drive quality objectives.
- Co-ordinate with production and R&D to identify realistic and impactful quality objectives
- and focal for each objective.
- Monitor the progress of each objective and aid focals to achieve the objectives.
- Document and update the objectives
- Internal quality audit and External audit
- Ensure availability of documents at the time of audit.
- Co-ordinate with regulatory team and fulfill the audit requirements.
- Ensure timely closure of audit findings.
- Prepare DMR for new products.
- Co-ordinate with R&D team in preparation of documents such as quality plan, SOPs, Risk
- analysis, MDD documents and technical specification etc.
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