Senior Executive, R&D Quality Assurance at Azurity Pharmaceuticals

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

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
Knowledge of ICH Stability studies

Responsibilities

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 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
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/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

Skills

GMP

Quality Assurance

Quality Control

Analytical Development

Stability Programs

Change Control

Deviation Investigations

Laboratory Notebooks

Calibration

Document Archival

Method Validation

Specifications Approval

Azurity Pharmaceuticals

Develops specialized formulations of medicines

About Azurity Pharmaceuticals

Azurity Pharmaceuticals develops specialized formulations of existing medicines to meet the needs of patients who are often overlooked by traditional pharmaceutical companies. Their products include oral suspensions and other forms that are easier to administer, particularly for those who have difficulty swallowing pills or need precise dosing. This focus on creating accessible and effective medications enhances patient compliance and addresses gaps in the pharmaceutical market. Azurity serves healthcare providers, hospitals, and pharmacies, generating revenue through the sale of FDA-approved proprietary medicines across various therapeutic areas, including cardiovascular, central nervous system, and oncology. Their goal is to improve patient outcomes by providing high-quality, innovative medicines tailored to specific medical conditions.

Woburn, MassachusettsHeadquarters

2000Year Founded

$182.2MTotal Funding

GROWTH_EQUITY_VCCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Company Match

401(k) Retirement Plan

Paid Vacation

Paid Holidays

Hybrid Work Options

Professional Development Budget

Tuition Reimbursement

Wellness Program

Risks

Product recalls, like Zenzedi's, can damage brand reputation and cause financial losses.

Integration challenges from Slayback Pharma acquisition may disrupt operations.

Reliance on FDA approvals means regulatory delays could impact product launches.

Differentiation

Azurity focuses on innovative dose forms for overlooked patient needs.

Their FDA-approved products ensure safety and efficacy in specialized formulations.

Azurity's acquisition of Slayback Pharma enhances its development and launch capabilities.

Upsides

Growing demand for personalized medicine aligns with Azurity's specialized dose forms.

Increasing chronic diseases boost need for Azurity's innovative drug delivery systems.

FDA's focus on novel formulations benefits Azurity's product pipeline.

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