Assistant Manager – Quality Assurance (Operating from Himachal Pradesh)

Job Title: Assistant Manager – Corporate Quality Assurance Department: Quality Assurance Location: Roaming 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.

B. Pharm / M. Pharm / M.Sc. (Pharmaceutical Sciences, Chemistry, or Life Sciences)