Synbiotics Ltd Hiring For Regulatory Affairs Professional
We have an urgent Job Opening for our API manufacturing facility at Padra, Vadodara Location.
EXECUTIVE/SR. EXECUTIVE REGULATORY AFFAIRS & COMPLIANCE
Company: Synbiotics Ltd.
Location : Luna, Padra, Vadodara
Qualifications : B.sc/B. Pharm/M.sc/M. Pharm
Experience : 2 to 8 Years
Department : Regulatory Affairs
Key Responsibilities:
Regulatory Affairs:
1. Facilitate and manage all activities related to regulatory filings with various national and international regulatory bodies.
2. Review all documentation, including validation procedures and stability studies, for inclusion in regulatory filings.
3. Respond to queries from regulatory authorities regarding submitted dossiers.
4. Provide support to the corporate regulatory affairs department for filing activities and compliance formalities.
5. Assist other group companies with regulatory filings as required.
Regulatory Compliance:
1. Stay updated on the latest regulatory changes and ensure compliance with regulatory and customer audit requirements.
2. Ensure Good Laboratory Practice (GLP) compliance within the Quality Control department. 3. Review and approve critical procedures, documents, and analytical method validation records.
4. Oversee the review of laboratory incidents, out-of-trend results, and out-of-specification findings. 5. Monitor calibration and validation status of all Quality Control instruments and equipment.
6. Facilitate the review of batch testing records and ensure audit/inspection findings related to Quality Control functions are addressed.
7 Participate in internal audits and self-inspections of the Quality Control department alongside Quality Assurance teams.
8. Perform additional responsibilities as assigned to meet organizational needs.
Interested candidates can send their CV on
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