1 - 3 years
1 - 3 Lacs
Posted:1 day ago|
Platform:
Work from Office
Full Time
We are hiring Research Officer at our R&D.
Location: Navi Mumbai
1. Prepare and review documentation: Ensure accuracy, completeness, and compliance with regulatory requirements for documents such as analytical methods, study reports, and validation protocols.
2. Prepare SOPs and STPs: Develop, review, and maintain Standard Operating Procedures (SOPs) and Study Protocols (STPs) to ensure compliance with regulatory requirements.
3. Justification of queries: Prepare responses to queries and deviations, ensuring justification and compliance with regulatory requirements.
4. Maintain AMC records: Maintain and track records of Annual Maintenance Contracts (AMC) for instruments and equipment, ensuring timely renewals and compliance.
5. Maintain documentation: Ensure all documents are up-to-date, and revisions are properly tracked and approved.
6. Collaborate with teams: Work closely with analytical scientists, quality assurance, and regulatory affairs teams to ensure documentation meets requirements.
7. Ensure compliance: Familiarize yourself with regulatory guidelines (e.g., ICH, FDA) and ensure documentation complies with these standards.
8. Improve processes: Identify opportunities to improve documentation processes and implement changes as needed.
9. Strong attention to detail and organizational skills, Excellent written and verbal communication skills, Ability to work independently and collaboratively and Familiarity with regulatory guidelines and documentation requirements.
Marksans Pharma
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