Instem
Website:
instem.com
Job details:
Validation (Solutions) Consultant
Location: Bangalore, Hybrid.
Status:Permanent, Full Time
Package: Competitive Salary (fixed), 5 Day Working Week, Flexible Working(with one-off allowance), Development & Opportunity (Personal & Technical), Group Medical Policy, Group OPD Cover, Personal Accident Cover, Term Life Cover, 26 Days Leave + 9 Public Holidays + Buy & Sell Scheme, Referral Scheme.
Why are we hiring a Solutions Consultant ? The Solutions Consultant uses knowledge and experience to provide individualized and tailored support, validation or SEND services to clients to help them solve business challenges, improve performance, and achieve strategic goals. Tasks will be tailored to the client’s needs during the consulting period.
Who’s Instem? Well, we’re a global provider of bespoke industry-leading software solutions and services, which facilitate the pre-clinical, and clinical phases of the drug discovery process. We have over fifteen products in our portfolio, used by over 700 pharmaceutical clients (including all the top 25!)
Instem is a unique, solutions-based organisation. We’ve doubled in size over the last 3 years through new business and product enhancement, but also via acquisition. Our growth plan is progressive, and we need you to help us reach that next level!
What’s the culture/environment like? For a global business of over 400 staff, we very much have a family feel. You’ll be part of a friendly, communal, solution based, flexible environment, where you’ll feel empowered, valued and accountable. We’ll invest in you as a person and encourage you to take part in companywide workshops for wellbeing, mental health, critical conversations, and strengths.
What are you responsible for?
- Change Management: Execute validation activities for SAP transport requests, patches, and system updates to ensure no impact on existing business processes.
- Test Execution: Author and execute CSV deliverables, including Test Plans, Test Scripts (IQ/OQ/PQ), and Summary Reports.
- Data Integrity: Perform routine audits of SAP system logs and audit trails to ensure compliance with ALCOA+ principles and 21 CFR Part 11.
- Deviation Handling: Manage and document system deviations; perform root cause analysis and coordinate CAPA (Corrective and Preventive Actions) where necessary.
- Compliance: Maintain the Traceability Matrix and ensure all system documentation is audit-ready at all times.
- Adherence to the Company’s Quality Management System to ensure that all work is handled Securely, Professionally and Diligently
Behavioral Competencies
- Confident and self-motivated
- Good communication skills and a client-focused mindset
- Good organizational skills
- Able to work within pre-set deadlines
Skills, Knowledge And Experience
- Technical: 2–5 years of experience in Computer System Validation (CSV) within a regulated industry (Life Sciences/Pharma).
- Systems: Practical experience navigating SAP modules and understanding GAMP 5 methodologies.
- Knowledge of applicable Instem Products to support customer’s needs.
Knowledge of our Quality Management System and its application to tasks associated with this role
- Knowledge of Industry Standards such as CDISC, SEND, CFR21pt11, GAMP5 would be an advantage
- Demonstrated experience using AI enabled tools in a professional setting to improve productivity, quality, or decision making. Candidates must be comfortable adopting new AI capabilities and applying them responsibly as part of their daily work.
- Proven written and verbal communication skills
- Good knowledge of Microsoft Office products
- Effective time management
Daily, millions of lives are improved by the Instem technologies and services that have been deployed by our clients. This is a fantastic opportunity for you to help save and prolong people’s lives, by doing what you do best!
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
Instem stores and processes data using an Applicant Tracking System (ATS). For more information regarding our privacy policy use the following link: https://www.instem.com/privacy/
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