- Location
- IND - Navi Mumbai, India
- Type
- Full-time
- Closing date
- Today
- Source
- Workday
Description
At ALS, we encourage you to dream big.
When you join us, you’ll be part of a global team harnessing the power of scientific testing and data-driven insights to build a healthier future.
Job Summary**
- Manage and control instrument application privileges and user access.
- Provide IT QA support for analytical instruments and associated software.
- Support and execute Computer System Validation (CSV) activities throughout the system lifecycle.
- Ensure GxP compliance, including data integrity, data security, audit trails, deviations, CAPA, change control, and system verification.
- Participate in regulatory inspections and audits (FDA, NABL, CDSCO, customer audits, etc.).
- Provide site-specific application and IT system support.
- Ensure adherence to site-specific IT and QA SOPs.
- Support instrument qualification activities (IQ, OQ, PQ).
- Perform data backup verification for instruments and periodic software verification every two years.
- Create and manage annual and monthly projects in instrument applications.
- Conduct and manage periodic access reviews for validated system
Job Qualifications**
- Strong knowledge of GxP regulations and data integrity principles.
- Hands-on experience in Computer System Validation (CSV).
- Understanding of 21 CFR Part 11 and Annex 11 requirements.
- Experience with analytical instrument software and validated systems.
- Knowledge of DMS, QMS, and firmware-based systems.
- Strong documentation, deviation handling, and CAPA management skills.
- Ability to coordinate effectively with cross-functional teams
- Familiarity with regulatory guidelines such as FDA, EU Annex 11, and data integrity requirements
- Ability to work in a regulated manufacturing and laboratory environment.
- Strong attention to detail and compliance-focused mindset.
- Ability to manage multiple systems and priorities simultaneously.
Working at ALS
The ALS team is a diverse and dedicated community united by our passion to make a difference in the world.
Our values are important to us, and shape how we work, how we treat each other and how we recognise excellence.
At ALS, you’ll be supported to develop new skills and reach your full potential. We invest in our people with programs and opportunities that help you build a diverse career with us.
We want everyone to have a safe, flexible and rewarding career that makes a positive impact on our people, the planet and our communities.
Everyone Matters
ALS is proud to be an equal opportunity employer and is committed to fostering an inclusive work environment where the strengths and perspectives of each employee are both recognised and valued.
ALS also welcomes applications from people with all levels of ability. Reasonable adjustments to support candidates throughout the recruitment process are available upon request.
Eligibility
To be eligible to work at ALS you must be a Citizen or Permanent Resident of the country you are applying for, or either hold or be able to obtain, a valid working visa.
How to apply
Please apply on-line and provide a resume & cover letter that best demonstrate your motivation and ability to meet the requirements of this role.
