Quality Assurance Specialist

3 weeks ago

India Medivant Healthcare Full time

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: 01

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:

Manufacturing Oversight:

 1. Shop Floor Oversight:

  • Monitor and oversee sterile injectable manufacturing activities on the shop floor to ensure adherence to cGMP, SOPs, and regulatory requirements
  • Provide real-time guidance and decision-making during production to ensure product quality and compliance

 2. Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR)

  • Prepare, review, and approve BMRs and BPRs to ensure accurate documentation and compliance with manufacturing procedures
  • Ensure completeness, accuracy, and timely review of all manufacturing records

 3. In-Process Quality Checks:

  • Perform in-process quality checks during manufacturing stages to ensure critical process parameters and product specifications are met
  • Review and verify product labels for accuracy, ensuring they meet regulatory standards and internal quality requirements
  • Document results and address deviations immediately to avoid process interruptions

 4. Line Clearance:

  • Conduct line clearance at critical manufacturing stages, ensuring equipment, materials, and personnel comply with procedural and environmental requirements

 5. Annual Product Quality Review (APQR)

  • Compile and analyze data for APQR, ensuring thorough review and identification of trends
  • Collaborate with cross-functional teams to implement improvements and corrective actions based on APQR findings

Quality Management System (QMS):

 1. Change Control:

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

 2. Deviation Management:

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

 3. CAPA (Corrective and Preventive Action):

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

 4. Out-of-Specification (OOS) and Investigations:

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

 5. Regulatory Compliance:

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

Key Skills and Competencies:

  • 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.

Education and Qualifications:

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

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