Synbiotics Limited, a leader in the production of fermentation-based Active Pharmaceutical Ingredients (APIs), is seeking qualified professionals for the roles of Executive and Sr. Executive in Regulatory Affairs & Compliance. The positions are based at the state-of-the-art manufacturing facility in Padra, Vadodara. This is an excellent opportunity for individuals with a background in regulatory affairs and compliance, especially those with experience in the pharmaceutical sector.
About Synbiotics Limited:
Synbiotics Limited is a pioneering pharmaceutical company with vast experience in manufacturing fermentation-derived products. As one of the few facilities in the world producing Amphotericin B, Synbiotics stands out as a key player in the global pharmaceutical landscape. The company's facility in Village Luna, Padra, near Vadodara, is designed to meet stringent national and international regulatory standards. Synbiotics collaborates closely with its group company, Asence Pharma Private Limited, to handle all commercial operations, ensuring that their products meet the highest quality standards.
Available Positions:
1. Executive / Sr. Executive - Regulatory Affairs & Compliance
- Department: Regulatory Affairs
- Location: Padra, Vadodara, Gujarat
- Qualifications: BSc, B Pharmacy, MSc, M Pharmacy
- Experience: 2 to 8 years in Regulatory Affairs and Compliance
- Key Responsibilities:
- Regulatory Affairs:
- Manage and facilitate all regulatory filings with national and international regulatory bodies.
- Review and prepare documentation, including validation procedures and stability studies, for regulatory submissions.
- Respond to queries from regulatory authorities regarding submitted dossiers.
- Provide support to the corporate regulatory affairs department for filing activities and compliance formalities.
- Assist other group companies with regulatory filings as needed.
- Regulatory Compliance:
- Stay updated on the latest regulatory changes and ensure compliance with audit requirements.
- Ensure adherence to Good Laboratory Practice (GLP) within the Quality Control department.
- Review and approve critical procedures, documents, and analytical method validation records.
- Oversee the investigation and resolution of laboratory incidents, out-of-trend results, and out-of-specification findings.
- Monitor the calibration and validation status of all Quality Control instruments and equipment.
- Facilitate the review of batch testing records and ensure all audit/inspection findings are addressed.
- Participate in internal audits and self-inspections alongside Quality Assurance teams.
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Synbiotics Hiring for Regulatory Affairs & Compliance - Executive, Sr. Executive[/caption]
How to Apply:
Interested candidates who meet the qualifications and experience requirements can apply by sending their CV to
hrd@synbiotics.in.
https://pharmastuff.org.in/job/synbiotics-hiring-regulatory-affairs-amp-compliance-executive-sr-executive
