Development Quality Assurance Specialist

Job Description: Development Quality Assurance Specialist
Position Overview
We are seeking a highly motivated and detail-oriented Development Quality Assurance Specialist to ensure compliance with regulatory requirements and quality systems across all departments. This role involves monitoring quality assurance activities, conducting internal audits, overseeing documentation practices, and supporting regulatory submissions. The ideal candidate will play a critical role in maintaining compliance with cGLP, cGMP, and other international regulatory standards.

Key Responsibilities
Regulatory Compliance & Quality Systems

• Ensure adherence to regulatory requirements, including Schedule-M, 21 CFR Parts 210, 211 & Part 11, and Eudralex Volume 4.
• Implement and regulate quality systems and SOP compliance across departments.
• Conduct internal audits and ensure timely resolution of findings.
• Ensure compliance with data integrity procedures.
• Oversee implementation of change control systems for evaluating process and document changes.
• Investigate incidents, deviations, and implement CAPA (Corrective and Preventive Actions).
• Provide responses for customer and regulatory audits.

Good Manufacturing & Laboratory Practices

• Implement sanitation, personal health, hygiene, and safety practices across the facility.
• Establish and monitor procedures for gowning, entry & exit controls, pest & rodent management, and PPE usage.
• Ensure compliance with cGLP, cGMP, and pharmacopeial requirements.
• Conduct employee training programs to ensure adherence to quality standards.
• Oversee employee health check-ups and compliance with safety protocols.

Documentation & Data Management

• Implement good documentation practices and ensure proper record maintenance.
• Prepare, review, and approve quality-related documents, including SOPs, specifications, protocols, and validation reports.
• Monitor document and data control processes.
• Maintain all records per regulatory requirements and support documentation for regulatory submissions.
• Review and approve risk assessments, stability studies, and validation protocols.
• Oversee numbering and tracking of products, materials, equipment, and documents.

Process & Equipment Monitoring

• Monitor day-to-day activities within the Development Quality Assurance department.
• Oversee the qualification of vendors and external service providers.
• Supervise the receipt, inspection, storage, and usage of raw materials and packaging materials.
• Ensure qualification and validation of all critical equipment, instruments, and facilities.
• Review and approve equipment/instrument master lists, preventive maintenance schedules, and calibration programs.
• Monitor contract laboratories and contract calibration services.
• Conduct root cause analysis and provide solutions for process improvements.

Product & Analytical Development Oversight

• Ensure compliance with stability-indicating analytical methods.
• Review and approve validation reports, analytical method development, and stability testing data.
• Monitor critical processes related to manufacturing and packaging activities.
• Approve specifications, standard test procedures (STPs), and general test procedures (GTPs).
• Oversee product artwork review and approval.
• Supervise equipment qualification, facility, and utility qualification processes.

Qualifications:

• Education:
• Bachelor's or Master's or Ph.D. degree in Chemistry, Pharmacy, Biochemistry, Biotechnology, or related field.
• Experience:
• 10+ years in developmental quality assurance, including 2+ years in a leadership role within a CRO or CDMO.

Preferred Qualifications:

• Experience in managing outsourced projects or working in a contract development and manufacturing environment.
• Familiarity with regulatory agencies’ expectations (FDA, EMA) for biological processes.