Overview
Validation and QMS Specialist – Sterile Injectables Jobs in Kochi, India at Medivant Healthcare
We Need a Candidate Currently Holding B1/B2 Visa of USA. 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.
2. Area
Qualification:
Oversee qualification of classified manufacturing areas (Grade A-D). Perform routine re-qualifications and environmental monitoring to ensure
regulatory compliance
.
3. 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.
4. Utility
Qualification:
Validate critical utilities such as HVAC, water systems (WFI), and compressed air systems. Ensure utilities meet cGMP standards and regulatory guidelines.
5. Cleaning Validation:
Establish and validate cleaning procedures for equipment and manufacturing areas. Review cleaning validation protocols and reports to ensure compliance with regulatory requirements.
6. 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): 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.
Title: Validation and QMS Specialist – Sterile Injectables
Company: Medivant Healthcare
Location: Kochi, India
Category: Healthcare, Quality Assurance – QA/QC
