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Research Associate - DQA

Research Associate - DQA

Stanford Laboratories

3 - 6 years

|

3 - 5 Lacs

Posted:5 hours ago| Platform:

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Skills Required

Stability Analysis SOP Bpr Bmr Documentation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Responsible for ensuring that all pharmaceuticals products developed with the R&D Department meet the highest quality standards.
Prepare and review regulatory dossier documents for DCGI, ROW and Export market business.
Ensure all the documents meet regulatory requirements and guidelines including quality.
Implement and maintain quality assurance systems and procedures for dosage preparation.
Ensure compliance for Good Manufacturing Practices (GMP), Good Laboratories Practices (GLP) and other relevant regulatory standards.
Collect, organize and review documents from F&D, ADL and other relevant departments.
Prepare and review SOPs, BMRs, BPRs, PV Protocols/Reports, Stability Protocols etc. to ensure accuracy and compliance with manufacturing protocols.
Manage quality documentation and records, including standards operating procedures (SOPs), Batch records and Test reports.
Compile and review Product Development Reports (PDRs) to document the formulation and development process of products.
Ensure all equipment is calibrated according to the schedule and the records are maintained.

Preferred candidate profile

Must have experience in OSD

Perks and benefits

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