- Validation Activities:
- Media Fill Studies: Plan, execute, and review media fill trials to ensure aseptic process integrity. Analyze results and recommend corrective actions when necessary.
- Area Qualification: Oversee qualification of classified manufacturing areas (Grade A-D). Perform routine re-qualifications and environmental monitoring to ensure regulatory compliance.
- Equipment Qualification: Develop and execute protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of manufacturing equipment. Review and approve qualification documents.
- Utility Qualification: Validate critical utilities such as HVAC, water systems (WFI), and compressed air systems. Ensure utilities meet cGMP standards and regulatory guidelines.
- Cleaning Validation: Establish and validate cleaning procedures for equipment and manufacturing areas. Review cleaning validation protocols and reports to ensure compliance with regulatory requirements.
- Process Validation: Perform process validation studies, including preparation of protocols, execution, and reporting. Assess process robustness and capability to ensure consistency in product quality.
- Quality Management System (QMS):
- Change Control: Review and approve change control proposals. Assess the impact of changes on validation and regulatory compliance.
- Deviation Management: Investigate deviations, identify root causes, and implement corrective actions. Document and trend deviations to monitor quality improvements.
- CAPA (Corrective and Preventive Action): Develop and implement CAPAs for identified issues. Track and verify CAPA effectiveness within the specified timeline.
- Out-of-Specification (OOS) and Investigations: Manage OOS, OOT, and conduct thorough investigations, and prepare investigation reports. Implement corrective actions to prevent recurrence.
- Regulatory Compliance: 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.
- Medivant Healthcare India
About Us · 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. · Job Description · We are seeking a highly skilled Quality Assuran ...
- Medivant Healthcare India 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 Healthca ...
- Medivant Healthcare India
Job Summary · This role requires a candidate with 10-15 years of experience in Quality Control Microbiology. The ideal candidate will be responsible for overseeing and performing all Quality Management System (QMS) activities for the Quality Control Microbiology department. · Key ...
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Validation And Qms Specialist – Sterile Injectables - India - Medivant Healthcare

Description
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.
Key Responsibilities
Key Skills and Competencies
Education and Qualifications
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Validation and QMS Specialist – Sterile Injectables
Medivant Healthcare- India
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Qc-micro Qms Specialist – Sterile Injectables
Full time Medivant Healthcare- India
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QC-Micro QMS Specialist – Sterile Injectables
Medivant Healthcare- India
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Quality Assurance Specialist
Medivant Healthcare- India
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Laboratory Quality Assurance
Full time Medivant Healthcare- India
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Quality Control
Full time Medivant Healthcare- India
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Quality Control
Medivant Healthcare- India
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Laboratory Specialist
Medivant Healthcare- India