Analytical Documentation officer
Brief team/department description:
- The analytical team at R&D is playing an important role in product development of various dosage forms. The analytical team involves different workflows like analytical method development, stability studies, involving method verifications at CMO/CTL and post filling activities.
- This role is with Azurity R&D Analytical Review team, which coordinates all product development team s analytical documents preparation such as SOP, COA, ATP, Specification and Method of analysis.
Principle Responsibilities:
- Preparation and upload of Standard operating procedures, Spec and MOA in DMS.
- Conducting training for good documentation practices.
- Archival of General analytical documents.
- Conducting SOP training whenever required.
- Notifying pharmacopeia updates to the analytical team and preparing the assessment report.
- Should have exposure in preparing the documents in electronic DMS and tracking of documents review and approval process.
Qualifications and Education Requirements
- Graduate / Postgraduate in Pharmacy or Science.
- minimum of 5 years of experience in pharmaceutical analytical R&D or QC comes under this category.
- Exposure in preparation of key analytical documents. Understating Good Laboratory Practices and Good Document Practices.
- Should have exposure in electronic DMS systems.
- Proficient in written and spoken English
