We are looking for QA Manager for US location
This position is responsible for managing all Quality Assurance (QA) activities, which fall under the QA Operations organization including drug substance and drug product release (clinical and commercial),, stability data review, equipment, systems, and method validation documentation reviews, and contract manufacturing audits.
Responsibilities and Job Duties:
Establish and lead cross-functional teams to address operational issues relating to quality events, product release, equipment/system, utilities.
product lot release documents. Maintain and communicate quality metrics to appropriate teams to ensure that product lots are released on time.
Review and Approve, Raw material and finished Applies risk management processes and principles
Implement QA Operations processes and procedures to ensure efficiency and compliance with regulations and guidance.
and creates and utilizes risk analysis tools when assessing quality related issues Review and approve deviations, change controls and
other operational quality events.
Implement QA Operations processes and procedures to ensure efficiency and compliance with regulations and guidance.
Applies risk management processes and principles
and creates and utilizes risk analysis tools when assessing quality related issues Review and approve deviations, change controls and
other operational quality events.
Train QA Operations staff on review, evaluation, and
risk assessment of quality events.
Develop the technical and bench knowledge of QA Operations staff to enable them to thoroughly assess quality events and associated risks.
Qualifies and maintains the qualification status of
each vendor, contract manufacturer and contract
testing laboratory.
Ensure that quality agreements with vendors, contract manufacturers and testing laboratories are up to date with business needs and quality content and are current.
Write, review, and approve QA SOPs supporting QA
Operations responsibilities. Prepares audit reports and communicates any critical or major issues to Head of Quality and Management.
Qualifications: B.Pharma /M.Pharma
Experience :
A minimum of 10 years of experience in quality assurance or quality compliance At least 2 years of experience in a life science GMP
regulated manufacturing facility A minimum of 2 years supervisory experience audits investigations, audit reports, and SOPS Knowledge, Skills and Abilities assessment tools
Hands-on experience hosting and participating in regulatory inspections Hands-on experience performing external quality
Hands-on experience writing comprehensive product
Demonstrated knowledge, interpretation and application of US, EU and ICH GMP regulations and
guidance. Demonstrated knowledge and application of risk
Excellent verbal and writing skills
Interested candidate can share their profile on mamta.pitale@cadilapharma.co.in
