Associate Quality Assurance Validation

Company: A Large Global Organization

Key Skills: QA, QA Validation, Injectable

Roles and Responsibilities:

• To prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification.
• To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Supervisor regarding any non-conformity from planning and execution.
• To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Supervisor and approved by Manager.
• To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Trackwise.
• To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date.
• To ensure samples withdrawal during process validation & keep Supervisor updated about any non-conformity.
• To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed. To ensure the CFS closure of respective documents.
• To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by Supervisor.
• To attend trainings of each protocol before execution of any validation and qualification activity.
• To collect data & compile summary report for submission to International Regulatory Affairs (IRA) for queries and ANDA.
• To update the protocols as per current regulatory requirement to improve the validation documents.
• To prepare VMP as per regulatory guideline or any audit compliance requirement and provide it to Supervisor for review & approve.
• To keep the validation document updated from GMP aspect as per regulatory expectation.
• Planning and execution of validation activities associated with QMS elements.
• To inform the activity or issues which might occurred during the shifts validation activities through daily meeting.

Skills Required:

• Knowledge of cGMP, GDP, and regulatory guidelines (USFDA, MHRA, EU, WHO, etc.)
• Hands-on experience in validation activities (equipment, utility, process, cleaning, and facility)
• Experience in preparing and executing validation protocols (IQ, OQ, PQ)
• Familiarity with Quality Management Systems (QMS), including Change Control, CAPA, OOS, and Deviations
• Proficiency in using electronic systems such as Trackwise for QMS documentation
• Good understanding of injectable manufacturing processes and sterile dosage forms
• Analytical and problem-solving skills for handling non-conformities and investigations
• Coordination and communication skills for working with cross-functional teams
• Ability to prepare technical documents like VMPs, validation summary reports, and regulatory submissions
• Attention to detail and strong documentation practices
• Time management and organizational skills to manage validation schedules and priorities
• Working knowledge of Microsoft Office (Word, Excel, PowerPoint)

Education: Bachelor's Degree in related field