Referso Jobs

Commissioning and Qualification (C&Q) Manager

SSOE, Inc. · Posted Nov 8, 2024

Open

Atlanta, Georgia, United States
Hybrid
Full-time · Manager
$150K–$200K per year

Commissioning and Qualification (C&Q) Manager

SSOE, Inc. · Posted Nov 8, 2024

Open

Atlanta, Georgia, United States
Hybrid
Full-time · Manager
$150K–$200K per year

IN-Specialist_CSV_ITRA_Advisory_Bangalore

PwC · Posted Nov 6, 2026

Open

Bengaluru, Karnataka, India
Full-time · Mid
4–8 years

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The role focuses on Computer System Validation (CSV), Software Testing, and IT Compliance within the internal audit function, helping clients build and deliver end-to-end internal audit services.

Responsibilities

Having 4-8 years of work experience in Computer System Validation (CSV), Software Testing and and IT Compliance.
Exposure in Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC).
Knowledge of SDLC methodology like Waterfall and Agile model and V model of CSV.
Experience in manual testing like Positive & Negative Testing, Regression Testing, Smoke, Sanity Testing and defect tracking and reporting.
Knowledge of GAMP5 Guideline, GxP, US FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles.

Requirements

M.Sc
B.Pharm
B.Tech
Bachelor Degree
Nice to have: Valgenesis

Skills

CSV Software Testing IT Compliance SDLC STLC GAMP5

Development Scientist II, Analytical Development and Clinical QC (ADQC)

AstraZeneca · Posted Nov 5, 2026

Open

New Haven, Connecticut, United States
On-site
Full-time · Mid
$112K–$168K per year
2+ years

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Lead and oversee analytical quality control testing performed by external laboratories to ensure compliance and scientific soundness for biologic drug substance and product programs.

Compensation

The annual base pay (or hourly rate of compensation) for this position ranges from $112,304.00 - $168,456.00 USD. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.

Responsibilities

Providing scientific and operational oversight of external analytical laboratories performing release, stability, characterization, verification, validation, and investigational testing for biologic drug substance and drug product programs.
Leading laboratory investigations from initiation through closure, including Out-of-Specification, Out-of-Trend, and atypical analytical results.
Serving as a primary technical liaison with contract laboratories, translating internal program requirements into clear testing requests, deliverables, timelines, and documentation expectations.
Reviewing analytical data and technical documentation, including protocols, raw data, investigation reports, method verification and validation reports, stability data, Certificates of Analysis, and other records needed to support material disposition and regulatory commitments.
Coordinating external testing activities across multiple programs, proactively tracking testing status, laboratory investigations, analytical reports, sample requirements, documentation, and critical-path deliverables.

Development Scientist II, Analytical Development and Clinical QC (ADQC)

AstraZeneca · Posted Nov 5, 2026

Open

New Haven, Connecticut, United States
On-site
Full-time · Mid
$112K–$168K per year
2+ years

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Lead and oversee external analytical laboratory activities for biologic drug substance and product programs, ensuring compliance with GxP and delivering high-quality data for regulatory and batch release purposes.

Compensation

Responsibilities

Provide scientific and operational oversight of external analytical laboratories
Lead laboratory investigations from initiation through closure
Serve as primary technical liaison with contract laboratories
Review analytical data and technical documentation
Coordinate external testing activities across multiple programs

Requirements

Ph.D. in Biochemistry, Chemistry or related discipline
Nice to have: Experience with external contract laboratories or contract development and manufacturing organizations
Nice to have: Analytical methods for biologic products such as chromatography, electrophoresis, potency or binding assays, particulate testing, compendial testing, microbiological methods
Nice to have: Experience with electronic quality and document-management systems
Nice to have: Experience supporting analytical method transfer, verification, validation, stability testing, process performance qualification, or clinical-to-commercial program transitions

Business Systems Analyst II

American Regent, Inc. · Posted Jun 17, 2026

Open

New Albany, Ohio, United States
3–6 years

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Business Systems Analyst II

Responsibilities

Obtain, analyze, document, and validate business, functional, and system requirements for new and existing applications supporting GxP business processes
Translate business and regulatory requirements into system‑based solutions in collaboration with IT, Quality, system owners, the business and vendors
Assess the impact of system changes on validated state, business processes, and data integrity
Support CSV activities across the system lifecycle, including implementation, configuration changes, upgrades, and retirement
Author, review, approve and maintain CSV deliverables including User Requirements Specifications (URS), Risk assessments, Functional Specification (FS), Configuration Specifications (CS), Security Specifications (SS), Design Specifications (DS), Qualification Protocols (IQ/OQ/PQ), Traceability matrices, Validation plans and summary documentation

Requirements

Bachelor’s degree in Information Systems
Bachelor’s degree in Engineering
Bachelor’s degree in Business
Bachelor’s degree in Computer Science
Bachelor’s degree in STEM related discipline

Skills

Business requirements elicitation

Qualification Lead - IT/OT

Avacone · Posted Nov 4, 2026

Open

Indianapolis, Iowa, United States

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Responsibilities

Ensure qualification of OT system and quality management for IT and OT systems per Customer Quality Manual and regulatory requirements
Author, review and approve various validation/qualification deliverables
Lead project test resources for validation/qualification activities
Act as project’s quality representative in testing activities, engaging with local site QA and/or QA eCPL
Report status of quality-related activities to key stakeholders

Skills

validation qualification GMP GAMP 5 EU GMP Annex 11 21 CFR Part 11 PLC SCADA DCS MES Historian IT/OT systems Kneat ValGenesis Veeva Vault TrackWise ServiceNow

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Senior QA Specialist - CSV

Johnson & Johnson · Posted Nov 4, 2026

Open

Wilson, North Carolina, United States
On-site
Full-time · Senior
6+ years

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Seeking a highly qualified Senior QA Specialist - CSV to join a new Biotherapeutics Manufacturing facility, focusing on CSV programs, data integrity, and risk-based validation for greenfield site technologies.

Responsibilities

Author, implement, and maintain site CSV and data integrity procedures
Contribute to the Validation Master Plan, computerized system inventory, and GxP/criticality assessments
Represent Quality Assurance on qualification teams across requirements, design review, construction, commissioning, qualification, and implementation
Provide consulting to the project management team to ensure appropriate quality systems are in place for new systems
Apply GAMP 5 (2nd Edition) critical thinking, ICH Q9(R1), and ASTM E2500 principles

Requirements

Bachelor's degree in a scientific, engineering, or computer science discipline
Nice to have: Sterile fill-finish
Nice to have: Isolator
Nice to have: RABS automation
Nice to have: Automated visual inspection

Skills

Computer System Validation (CSV)Data Integrity GxP Pharmaceutical industry

Senior QA Specialist - CSV

6084-Janssen Research & Development Legal Entity · Posted Nov 4, 2026

Open

Wilson, North Carolina, United States
Senior
6+ years

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Senior QA Specialist focused on CSV and data integrity at a new Biotherapeutics Manufacturing facility.

Responsibilities

Author, implement, and maintain site CSV and data integrity procedures
Represent QA on qualification teams across design review, construction, commissioning, qualification, and implementation
Apply GAMP 5, ICH Q9, ASTM E2500 principles for risk-based validation
Review and approve URS, FRS, HDS, SDS, configuration specifications, testing plans, and validation reports
Ensure deviations and CAPAs are documented and closed

Requirements

Bachelor's degree in a scientific, engineering, or computer science discipline
Nice to have: Validation experience with sterile fill-finish, isolator or RABS automation
Nice to have: Experience with automated visual inspection
Nice to have: Experience with combination products or device assembly
Nice to have: MES/electronic batch record experience

Skills

QA oversight of CSV for automated manufacturing equipment and systems GAMP 5 (2nd Edition) knowledge 21 CFR Part 11 compliance

Advanced Software Engr

Honeywell · Posted Nov 4, 2026

Open

Bengaluru, Karnataka, India

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A QMS Validation Specialist in the Life Sciences industry is responsible for ensuring that Quality Management System (QMS) software operates accurately, securely, and in compliance with strict regulatory standards.

Responsibilities

Create, review, and execute validation lifecycle documents, including Validation Plans (VP), User Requirement Specifications (URS), Functional Requirements Specifications, Traceability Matrices (RTM), and Test cases for IQ/OQ/PQ.
Ensure QMS systems align with global life science regulations like FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines for software validation.
Conduct risk assessments (e.g., FMEA) to identify and mitigate compliance or data integrity gaps.
Manage software changes, deviations, and Corrective and Preventive Actions (CAPA).
Develop training materials and Standard Operating Procedures (SOPs) to ensure end-users utilize the QMS software securely and compliantly.

Requirements

Bachelor’s degree in Life Sciences
Bachelor’s degree in Biotechnology
Bachelor’s degree in Computer Science
Bachelor’s degree in Engineering

Skills

TrackWise Digital Veeva Vault Quality MasterControl ValGenesis GAMP 5 data integrity principles electronic signatures regulations

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ValGenesis jobs

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