Senior Manager - Analytical Quality Assurance (AQA)

Rubicon Research; Indore District, Pithampur; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Rubicon Research is seeking a qualified professional to support Analytical Quality and regulatory compliance within GMP norms. You will review GLP-related documents, perform CAPA and deviation assessments, and help ensure successful batch release and retention sample management.

The role requires expertise in HPLC/GC/KF/FTIR, experience with regulatory inspections, and the ability to coordinate a team across QC, Manufacturing, and Engineering. Domestic travel may be required.

Qualifications

• Must be qualified minimum in B. Pharm/M. Pharm/M.Sc.(Chemistry or relevant).
• Sound knowledge on handling HPLC, GC, KF, FTNIR, FTIR.
• Exposure to regulatory audits from US FDA, MHRA, TGA, ANVISA is preferred.

Responsibilities

• Support Lab - Analytical Quality and compliance per GMP norms.
• Review GLP, OOS, OOT, CAPA, Deviation, Incident and Change Control documentation.
• Review and approve certificates of analysis from QC for finished products; assist batch release.

Skills

Team coordination

Team planning

Education

B. Pharm

M. Pharm

M.Sc. (Chemistry or relevant)

Tools

HPLC

GC

KF

FTNIR

FTIR

Job description

Role & responsibilities

Job Description

To support Lab - Analytical Quality and compliance is maintained as per the GMP norms

Well versed in the analytical review which includes review of GLP, OOS, OOT, CAPA, Deviation, Incident and Change Control. Review of analytical documents and electronic records which include worksheet, chromatograms, AMT/AMV, FP/IP/Audit trails/Qualification data of instruments, Analysts. Preparation of Standard operating procedures and harmonization of the practices. To review and approve the Certificate of Analysis received from QC for Finished Product. Support batch release activities. Retention sample management. Review and ensure compliance of computer system validation as per 21 CFR Part11 and EudraLex Annex11. Review of stability protocol and reports. Ensure Laboratory compliance. Check rounds of lab and internal auditing. Review of specifications & STP. Responding to customer communications and queries. Participate in customer and regulatory inspections and ensure CAPA preparedness and effectiveness check. Leading the group independently in the absence of In-charge

Preferred candidate profile

Must be qualified minimum in B. Pharm/M. Pharm/M.Sc.(Chemistry or relevant). Must have sound knowledge on handling HPLC, GC, KF, FTNIR, FTIR. Exposure to regulatory audits from various regulatory bodies like US FDA, MHRA, TGA, ANVISA. Exposure to specialized dosage forms such as OSD and nasal formulations is recommended. Knowledge of handling data related to OSD and Nasal is a must. Team coordination and work distribution. Planning for the team and coordination with functions like QC, Manufacturing, Engineering, Warehouse. Exposure to microbiology and manufacturing activities are preferred.

Additional Notes:

Expected to visit Satara, Thane, or other manufacturing sites on need basis and as per business requirements.