Job Description

• This position is ideal for an experienced QA professional looking to lead and enhance Quality Management Systems (QMS), cGMP, and GLP processes within a regulated manufacturing environment. The role requires strong analytical, documentation, and audit-readiness capabilities, along with leadership skills to guide QA teams effectively.

Key Responsibilities

Quality Systems & Compliance

• Ensure all manufacturing practices comply with cGMP, GLP, GMP+, ISO, FDA and other regulatory standards.
• Manage QMS activities including change control, validations, stability, qualifications, APQR, and risk assessments.
• Maintain documentation required for internal and external audits.
• Handle applications and compliance activities such as AHC to AQCS, EIA, Capexil and related processes.

Audit Management

• Organize, coordinate, and support internal and external audits.
• Maintain audit records and ensure timely closure of audit findings.

Quality Operations

• Evaluate and approve suppliers for RM, PM, testing labs, and service providers.
• Assist in investigation of deviations, OOS, incidents, and ensure CAPA implementation.
• Support customer complaint investigations and preparation of related reports.
• Review BMR documents, ensure updates, and guide operators for required documentation changes.
• Review and manage label artwork.

Team Coordination

• Monitor availability of QA operators and allocate tasks as required.
• Collaborate with cross-functional teams for smooth QA operations.

Required Qualifications

• B.Pharm, B.Sc, or M.Sc in Chemistry or Microbiology.
• Minimum 8 years of QA experience in pharmaceutical, food processing, cosmetics, or chemical industries.

Technical Skills

• Strong analytical and problem-solving skills.
• Knowledge of GMP, GLP, GDP, and regulatory guidelines.
• Excellent documentation and report-writing skills.
• Good communication skills (verbal and written).