Sr. Associate, Validation
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Summary of Position:
At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 associates we innovate fearlessly champion progress and act swiftly to impact global eye health. We foster an inclusive culture recognizing your contributions and offering opportunities to grow your career like never before. Together we make a difference in the lives of our patients and customers. Are you ready to join us
This role is part of Alcons Quality & Regulatory Affairs function a team that ensures our products are in compliance with global local and internal regulations and meet the strictest standards of quality as we help people see Sr. Associate Validation (Science/Tech/Engineering Path) is primarily responsible for supporting and completing validation and qualification activities for processes equipment systems and facilities. You will prepare review and rectify validation protocols provide technical support and help manage department expenses.
Key Responsibilities:
Perform specialized technical tasks and conduct research to optimize validation outcomes
Ensure equipment systems and processes operate effectively and comply with regulations
Conduct risk assessments design protocols analyze data and prepare validation and qualification reports
Verify that products and processes meet predefined criteria
Support validation activities for aseptic process management
Review and approve change control documentation
Provide audit support and develop protocols for product transfers and launches
Make decisions within the scope of assigned tasks requiring advanced technical knowledge and analytical skills
Adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs) and maintaining accurate documentation
Ensure rigorous quality control complete all required training and contribute to overall compliance
Commit to continuous improvement and compliance with regulatory requirementsAll associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs) maintaining accurate and complete documentation ensuring rigorous quality control and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.
Key Requirements/Minimum Qualifications:
- 4-8 years of total experience with bachelors degree.
- Writing validation documentation that include installation operation & performance qualification.
- Reviewing statistical data and technical reports.
- Conducting gap assessment & generating test scripts.
- Reviewing changes & documenting validation plans and activities.
Work hours: 1 PM to 10 PM IST
Relocation assistance: Yes
Employment Scams:Alcon is aware of employment scams which make false use of our company name or leaders names to defraud job seekers. Alcon does not offer any positions without interview and never asks candidates for money. All our current job openings are displayed here on the Careers section of our website where you can search for open positions and apply directly.
If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent we strongly recommend you do not respond send money or personal information and check our website for current job openings.
ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon please click the appropriate link below to apply on the Internal Career site.
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Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity marital status disability or any other reason.
Required Experience:
Senior IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Our mission is to provide innovative vision products that enhance quality of life by helping people see better. From vision research to eye health, learn more at Alcon.com.
