Senior Executive, R&D Quality Assurance

Azurity Pharmaceuticals

2 - 6 years

3 - 6 Lacs

hyderabad

Posted:2 weeks ago| Platform:

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Skills Required

neurology manager quality assurance microbiology cardiovascular pharma analytical stability studies manager quality control gmp endocrinology

Work Mode

Work from Office

Job Type

Full Time

Job Description

This role supports that R&D Quality Assurance organization with know-how in GMP, Quality Control, Analytical Development, and management of stability programs.

Principle Responsibilities:

Quality Assurance Oversight of Internal R&D Laboratory:

Provide Quality Assurance oversight to the laboratory, manufacturing, and analytical control activities of R&D Laboratory in Hyderabad
- Oversee laboratory change controls, investigation reports and incidents for their timely closure
- Oversee of Stability Chamber s data logs and reports review.
- Issuance of laboratory Notebooks (LNBs) and Usage Logs and retrieval/archival of documents (LNBs, Usage Logs, calibration documents, raw data files, qualification documents etc).
- Approval of specifications and methods of analysis of Active pharmaceutical Ingredients, Finished Products, Excipients, Primary Packing Material used in R&D laboratory.

Analytical Quality Assurance with external CMOs/Labs:

Quality oversight of analytical method transfers from the R&D laboratory to the GMP vendor for pipeline products, and between two GMP vendors for already approved products.
Quality oversight of analytical data of registration/validation batches aimed at supporting new marketing authorization application.
Review and approve analytical method transfer, analytical method verifications, analytical method validation, and CMC documentation (Microbiology and Chemical tests) including pre-transfer support to Quality Control of the R&D laboratory.
In collaboration with R&D Quality Operations, conduct batch review and technical release of registration batches (no market release) and review/approve its related documentation such as OOSs, change control, CAPA.
Ad-hoc support of the commercial Quality Operations Team with investigations related to significant out-of-specifications and product complaints of commercial products.
Review and approval analytical CMC documentation prior to regulatory filing related to new submissions and to already approved products (i.e. post-approval changes).
Oversee the Pilot bio batch manufacturing and batch clearance for Bio Availability/Bio Bioequivalence studies.
Support the qualification of GMP vendors located in India, with local auditing.
Oversight of R&D stability studies enabling new drug applications.
Approval of Master equipment list and Master calibration schedule in R&D.

Qualifications and Education Requirements

5+ years of experience in Quality Assurance or Quality Control in Pharmaceutical Companies
Bachelor of Science in Chemistry or Pharmaceutical Sciences.
Experience with Analytical Methods development/validation is necessary.
Knowledge of ICH Stability studies

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