Job Title:
Assistant Manager – Corporate Quality Assurance
Department:
Quality Assurance
Location:
Roaming Profile (Himachal Pradesh, North India)
Reports to:
Manager – Corporate QA
Job Purpose:
To support and oversee implementation of Quality Management Systems (QMS) across manufacturing facilities, third-party units, and vendors, ensuring compliance with cGMP, regulatory guidelines, and corporate quality policies.
Key Responsibilities:
Quality Systems Implementation & Oversight:
Monitor and support the execution of corporate quality procedures, policies, and SOPs at plant and third-party sites.
Ensure compliance to QMS elements like change control, deviations, CAPA, risk assessment, and product complaints.
Documentation Control & Review:
Review and approve SOPs, master documents, validation protocols, and quality agreements from a corporate QA perspective.
Maintain central document control for corporate QA records in compliance with GDP.
Regulatory & Compliance Support:
Assist in preparation for regulatory and customer audits.
Track and ensure closure of audit observations, including CAPA monitoring and effectiveness checks.
Site & Vendor Quality Support:
Coordinate with manufacturing sites and contract manufacturing organizations (CMOs) for quality data, compliance updates, and quality system improvements.
Support vendor qualification and requalification audits along with CAPA follow-ups.
Data Integrity & Risk Management:
Participate in data integrity assessments and ensure compliance with ALCOA+ principles.
Support risk assessments related to processes, products, and quality systems.
Training & Communication:
Conduct and coordinate training on quality systems and regulatory updates.
Circulate regulatory changes, inspection trends, and corporate quality updates across sites.
Quality Metrics & Reporting:
Compile and report site-wise quality KPIs and compliance trends to management.
Prepare quality dashboards, audit summaries, and compliance status reports.
Key Requirements:
Education:
B. Pharm / M. Pharm / M.Sc. (Pharmaceutical Sciences, Chemistry, or Life Sciences)
