Validation and QMS Specialist - Sterile Injectables

About Company: Medivant Healthcare is a pioneer in the pharmaceutical industry, providing high quality products reliably, efficiently, affordably, and at scale for hospitals, healthcare providers, and their patients. Founded in 2015 and based in Phoenix, Arizona, Medivant Healthcare operates two fully automated CGMP FDA registered facilities in Arizona, that produce Single Dose liquid injectable vials and pre-filled syringes. Experience Required: 10-15 years Location: Remote/On-site Department: Quality Assurance Salary: As per Market Standard No. of vacancy: 02 Mandatory Requirements: Valid B1/B2 Visa for the USA. Willingness to travel for work, including international travel to the USA and other regions as required. Have to work as per US timings when working remotely. Key Responsibility: Validation Activities: 1. Media Fill Studies:

• Plan, execute, and review media fill trials to ensure aseptic process integrity.
• Analyze results and recommend corrective actions when necessary.

• Oversee qualification of classified manufacturing areas (Grade A-D).
• Perform routine re-qualifications and environmental monitoring to ensure regulatory compliance.

• Develop and execute protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of manufacturing equipment.
• Review and approve qualification documents.

• Validate critical utilities such as HVAC, water systems (WFI), and compressed air systems.
• Ensure utilities meet cGMP standards and regulatory guidelines.

• Establish and validate cleaning procedures for equipment and manufacturing areas.
• Review cleaning validation protocols and reports to ensure compliance with regulatory requirements.

• Perform process validation studies, including preparation of protocols, execution, and reporting.
• Assess process robustness and capability to ensure consistency in product quality.

• Review and approve change control proposals.
• Assess the impact of changes on validation and regulatory compliance.

• Investigate deviations, identify root causes, and implement corrective actions.
• Document and trend deviations to monitor quality improvements.

• Develop and implement CAPAs for identified issues.
• Track and verify CAPA effectiveness within the specified timeline.

• Manage OOS, OOT and conduct thorough investigations, and prepare investigation reports.
• Implement corrective actions to prevent recurrence.

• Ensure adherence to cGMP, US FDA and other regulatory requirements.
• Participate in internal and external audits and inspections.

• In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
• Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.).
• Strong analytical and problem-solving skills.
• Effective communication and documentation skills.
• Ability to manage cross-functional teams and prioritize tasks.
• Proficiency in QMS tools and software.

• Bachelor’s/Master’s degree in Pharmacy, Biotechnology, Microbiology, or related field.