Senior Quality Assurance Professional
6 hours ago
As a Quality Assurance Specialist, you will play a crucial role in ensuring the integrity of our manufacturing processes. This includes preparing, reviewing, and approving validation protocols and reports for media fill studies to guarantee aseptic process integrity.
About the Role:
This is a challenging opportunity for a seasoned professional with 10-15 years of experience in the pharmaceutical industry. You will be responsible for analyzing remote media fill results, identifying deficiencies, and recommending corrective or preventive actions.
Main Responsibilities:
- Develop and maintain area qualification protocols and reports for classified manufacturing areas (Grade A–D) based on environmental monitoring and qualification data from the site.
- Analyze periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements.
- Prepare, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment.
- Support and participate in Factory Acceptance Test (FAT) execution for equipment at vendor locations (onsite when required, otherwise through live remote connection).
- Develop and review utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation.
- Prepare, review, and approve cleaning validation protocols and reports to ensure adequacy, compliance, and suitability for product changeover.
- Maintain and update the Validation Master Plan (VMP), ensuring alignment with regulatory expectations and site needs.
Requirements:
To succeed in this position, you must have:
- 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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