Sr. Associate, Validation

Alcon Laboratories

4 - 8 years

3 - 7 Lacs

bengaluru

Posted:Just now| Platform:

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Skills Required

standard operating procedures risk management risk assessment pharmaceutical oracle quality control iso production internal control documentation auditing training gmp internal audit computer assembling change control java sop quality assurance qms

Work Mode

Work from Office

Job Type

Full Time

Job Description

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 bachelor s 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.

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