Sr Analyst-Quality
West Pharmaceutical Services · Bengaluru · onsite · Posted 16d ago
Undisclosed5–8 yrsfulltimeSourced from
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About this role
Work Location Logistics
Job Summary
Essential Duties and Responsibilities
Additional Responsibilities
Education
Work Experience
Preferred Knowledge, Skills and Abilities
Travel Requirements
Physical Requirements
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Onsite/Hybrid/Remote: This is an onsite position requiring the team member to be onsite for all scheduled workdays.
Hybrid: This is a hybrid position requiring the team member to be onsite for 3 days per week.
Remote: This is a remote position allowing the team member to work from home.
Relocation: Is relocation assistance provided or not
This position offers relocation assistance.
No relocation assistance is provided for this opportunity.
Sponsorship: Is Sponsorship provided or not for this opportunity.
Job Summary
The Senior Analyst - Digital Quality Assurance acts as an independent quality reviewer and approver for Computer Software Validation (CSV) documentation. This role ensures that all GxP computer systems comply with Wests procedures, global quality standards, and applicable regulatory requirements.
As a key member of the Digital Quality Assurance (DQA) team, the Senior Analyst partners closely with cross-functional stakeholders, including the Project Team, Digital & Technology (D&T) teams (especially the Validation and Infrastructure groups), and Site/Business representatives(as applicable).
Essential Duties and Responsibilities
- Ensure adherence to West s global CSV procedures and support the qualification and validation of new or upgraded GxP software applications and process improvements.
- Collaborate with project and technical teams to ensure regulatory and quality requirements are clearly defined, documented, and implemented for GxP applications.
- Review test protocols, test execution records, and deviations, ensuring complete and compliant evidence of validation testing.
- Review and approve change control documentation related to GxP computerized systems to ensure continued compliance and system integrity.
- Review and approve periodic reviews of GxP computer systems to verify compliance with current procedures, standards, and regulations.
- Deliver training and guidance to D&T teams, including validation engineers and system owners, on CSV processes, data integrity principles, and the application of quality system procedures.
- Support the Digital QA Lead during internal and external audits, inspections, and assessments related to QMS and CSV documentation.
- Participate in the preparation, review, and approval of Quality Assurance documentation related to digital systems, including quality plans, risk management records, and audit responses.
- Contribute to the creation, review, and periodic update of CSV procedures and work instructions, aligning them with current regulatory expectations and industry best practices.
- Participate in global quality initiatives and events, collaborating across teams to strengthen quality culture and promote continuous improvement within digital systems compliance.
Additional Responsibilities
- Ensure adherence to corporate Quality System requirements
Education
- Bachelor s degree in Life Sciences, Engineering, Computer Science, or a related discipline.
Work Experience
- Minimum 5-8 years of experience in regulated Quality Assurance / Quality Control required and
- Experience with qualifications, Quality Risk Management, quality systems such as ISO 13485, 21 CFR 820, ISO 14971, Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities, MasterControl, SAP, Share Point, Teamcenter preferred
Preferred Knowledge, Skills and Abilities
- Ability to work independently, multi-task and thrive in fast-paced environment
- Must have effective problem solving and interpersonal skills
- Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
- Able to comply with the company s safety policy at all times
- Comprehensive knowledge of the end-to-end Computer System Validation (CSV) process, including planning, execution, documentation, and maintenance.
- Familiarity with the Computer Software Assurance (CSA) approach and its application in risk-based validation strategies.
- Understanding of Agile and Waterfall methodologies used in software development and validation lifecycle.
- Strong interpersonal, communication, and teamwork abilities, with a proven capacity to work collaboratively under guidance in a cross-functional environment.
Travel Requirements
5%: Up to 13 business days per year
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
SAPAgileAuditingManager Quality AssuranceManager Quality Controltest executionLogisticsHealthcareRisk ManagementComputer Science
About West Pharmaceutical Services
West Pharmaceutical Services
Pharma
281
employees
1923
103 years old
Exton, Pennsylvania
United States
₹18.9L PA avg
Avg at West Pharmaceutical Services
About
West Pharmaceutical Services, Inc. is one of the leading manufacturers of packaging components and delivery systems for injectable drugs and healthcare products.
Industries
PharmaHealthcare / PharmaManufacturing
Employee ratings
10 reviews
3.5/ 5
Culture
3.8
Career growth
3.1
Work-life
4.0
Employees rate it well for
Work-Life Balance37Company Culture35
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