AGM/GM- Quality Assurance

Role & responsibilities

• Lead strategic quality initiatives

  across multiple plants, aligning with business goals and customer expectations.

• Establish and drive a best-in-class quality culture

  ensuring compliance with GxP and global regulatory standards.

• Design and implement robust quality systems

  and policies to support product excellence and regulatory readiness.

• Oversee validation and qualification activities

  for processes and equipment in line with production plans.

• Ensure timely product transfers and documentation

  TT Documents, BMR, BPR) for successful site launches.

• Monitor and respond to regulatory communications

  ensuring timely submissions and compliance.

• Institutionalize quality checks and controls

  to maintain high standards across all stages of product development.

• Drive continuous improvement initiatives

  through internal audits, SOP enhancements, and quality reviews.

• Champion training and development

  for quality teams on regulatory updates, compliance, and technical skills.

• Ensure audit readiness and regulatory compliance

  across all plant locations with proactive risk management.

• Expertise in Data Integrity (ALCOA), GLP, and GDP

  ensuring reliability, traceability, and compliance in all quality records and laboratory practices.

• Strong grasp of regulatory guidelines and pharmacopeial standards

  (IP, BP, EP, USP) with hands-on experience in QMS documentation and compliance frameworks.

• Proficient in investigation methodologies

  .

• Skilled in equipment/instrument qualification & validation

  and analytical method validation to support robust quality control and regulatory readiness.

• Effective communicator with working knowledge of SAP, MS Word & Excel

  , enabling seamless documentation, reporting, and cross-functional collaboration.

• Must have exposure of regulatory Audits

  like USFDA & EU-GMP etc.