IT - Computer System Validation (CSV) Specialist 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

Bachelor’s degree in Computer Science, Information Management, or related field
5+ years in an IT QA/IT-Computer System Validation (CSV) position, preferably in life sciences/pharma
In-depth understanding of regulatory standards such as 21 CFR Part 11, GxP, FDA, and EU GMP Annex 11
Relevant knowledge on Information Technology, Pharmaceutical or Medical Device experience
Knowledge of GxP and other validation requirements in the pharmaceutical industry
Self-starter who is well organized and is an effective communicator who takes the initiative in meeting personal, departmental, and corporate goals
Capable of working in fast-paced environments, embracing change, and taking smart risks

Responsibilities

Develop, review, and execute the IT-CSV deliverables like Validation Plan, Validation Summary Report, Trace Matrix, IQ/OQ/PQ protocols (Installation Qualification, Operational Qualification, Performance Qualification) for computer systems, applications, and IT infrastructure
Conduct risk assessments for validation projects and identify mitigation strategies
Perform risk-based validation to prioritize testing efforts based on system impact
Ensure that all validation documentation (URS, traceability matrices, validation reports, etc.) is complete, accurate, and in compliance with applicable regulations and internal SOPs
Interface with key IT and business stakeholders to understand requirements
Provide subject matter expertise for IT impacts requiring CSV verification and validation, including to GxP and other validation requirements as applicable
Create and ensure proper documentation is created for testing of validated systems
Interface with the Enterprise Program Management Office to incorporate IT QA activities into broader project plans and timelines

Skills

Key technologies and capabilities for this role

CSVComputer System Validation21 CFR Part 11Annex 11GxPregulatory compliance

Questions & Answers

Common questions about this position

What experience is required for the IT - Computer System Validation (CSV) Specialist role?

The role requires deep expertise in the pharmaceutical domain and hands-on experience in authoring, reviewing, and managing CSV documentation, including Validation Plan, Validation Summary Report, Trace Matrix, IQ/OQ/PQ protocols, URS, and traceability matrices.

What regulatory standards must the CSV Specialist ensure compliance with?

The specialist must ensure IT systems and regulated environments adhere to 21 CFR Part 11, Annex 11, GxP, and other relevant regulatory frameworks.

What is the company culture like at Azurity Pharmaceuticals?

Azurity fosters an inclusive workplace with a talented, dedicated team focused on patient benefits through quality and science; the Digital team builds transformative capabilities in fast-paced environments that embrace change and smart risks.

What qualities make a strong candidate for this CSV Specialist position?

Strong candidates are highly motivated with dedication, integrity, creative spirit, passion for compliance, innovation, continuous learning, and the ability to thrive in fast-paced environments while embracing change and taking smart risks.

Is the salary or compensation specified for this role?

This information is not specified in the job description.

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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