Assistant Manager - Quality Assurance

Sava Healthcare

Posted: 5 months ago
Openings: 10
Applicants: 0

Job Description

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)