Sr. Officer Compliance-QC

3 - 7 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Zeiss Pharmaceutical, Jharmajri, Baddi

time outline icon Samba, Jammu and Kashmir, India

Posted on 05-04-2024

1 Vacancy

Description

Ensure compliance of QC operations with regulatory requirements, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulations from agencies such as FDA, EMA, and ICH.
Develop, implement, and maintain quality management systems (QMS) elements within the QC department, including document control, change control, deviations, investigations, and CAPA (Corrective and Preventive Actions) processes.
Prepare for and participate in internal and external audits and inspections of QC operations, including conducting self-assessments and ensuring readiness for regulatory audits.
Monitor QC activities to ensure compliance with established procedures, regulations, and industry standards, including conducting periodic reviews and assessments.
Manage and maintain accurate and up-to-date documentation related to QC operations, including SOPs, protocols, batch records, and quality records.
Perform risk assessments related to QC processes and systems, identifying potential risks and implementing appropriate controls to mitigate them.
Provide training and education to QC personnel on regulatory requirements, compliance procedures, and quality systems.
Conduct investigations into non-conformances, deviations, and out-of-specification results, including root cause analysis and implementation of corrective and preventive actions.