Regulatory Affairs
Executive (2-5 years experience)
Location: Jeedimetla, Hyderabad
Responsibilities:
- Compilation of USDMFs according to GDUFA requirements in eCTD format.
- Preparation of annual reports and amendments to USFDA.
- Drafting responses to comments received from regulatory authorities.
- Coordinating with cross-functional teams for data collection and interpretation for DMF submissions.
Walk-in Interview: September 18-20, 2024, 9:30 AM – 2:30 PM
Production
Chemist (1-5 years experience)
Location: Kazipally, Sangareddy
Responsibilities:
- Execution of batch production records like MBPRs, cleaning BPRs, etc.
- Indenting and receiving raw materials and general items.
- Planning batch movement and maintaining records according to standard operating procedures.
- Following validations as per protocols (process/cleaning).
- Ensuring proper storage and handling of raw materials and intermediates.
Walk-in Interview: September 19-20, 2024, 9:30 AM – 3:00 PM
Quality Assurance
Chemist (2-5 years experience)
Location: Kazipally, Sangareddy
Responsibilities:
- Issuance, receipt, and review of BPRs, cleaning records, forms, and records.
- Preparation, review, issuance, and archival of SOPs.
- Monitoring and reporting production activities.
- Verifying calibration records of weighing balances.
- Preparing and reviewing for annual product review/product quality review.
- Managing document issuance, retrieval, and archival.
Walk-in Interview: September 19-20, 2024, 9:30 AM – 3:00 PM
Quality Control
Chemist (2-5 years experience)
Location: Kazipally, Sangareddy
Responsibilities:
- Issuance, receipt, and review of BPRs, cleaning records, forms, and records.
- Preparation, review, issuance, and archival of SOPs.
- Monitoring and reporting production activities.
- Verifying calibration records of weighing balances.
- Preparing and reviewing for annual product review/product quality review.
- Managing document issuance, retrieval, and archival.
Walk-in Interview: September 19-20, 2024, 9:30 AM – 3:00 PM
About Aurore Life Sciences:
Aurore Life Sciences is a leading API manufacturer committed to delivering high-quality products in a regulatory compliant environment. We are seeking talented individuals to join our growing team.
