Chief Quality Excellence Officer

2 days ago

Bareilly, Uttar Pradesh, India beBeeQuality Full time ₹ 18,00,000 - ₹ 21,90,000

Job Summary

As a seasoned Quality Assurance professional, you will play a pivotal role in ensuring the excellence of our products.

  • Key Responsibilities:
  • Develop and implement robust quality audit processes, maintaining adherence to GMP standards and regulations.
  • Coordinate vendor qualification activities for raw materials, packing materials, quality control external testing laboratories, and outsourced services.
  • Conduct internal audits, compliance audits, Qualified Person audits, and regulatory inspections to ensure seamless operations.
  • Lead the close-out of CAPA initiatives resulting from all audits and inspections.

Additional Responsibilities

  • Establish a robust Quality Management System (QMS) to effectively manage change management, deviation management, incidents, complaint handling, and CAPA management.
  • Oversee investigations into non-conformances, including deviations, complaints, and other issues.
  • Manage product recalls and develop/maintain systems to implement ICH Q8 (QBD), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System) requirements.
  • Ensure cGMP requirements and quality standards are recognized, understood, and maintained across the organization.
  • Develop batch release and reject systems to guarantee quality products reach the market.
  • Collaborate with cross-functional teams to maintain a state of readiness for regulatory agency inspections.

Leadership Responsibilities

  • Lead, manage, and provide relevant training on change management programs throughout the organization.
  • Offer quality guidance to product development projects and programs.
  • Be responsible for data integrity internal audits, training, review, and reporting to leadership.
  • Maintain and improve departmental operational performance to meet regulatory authorities' requirements, company SOPs, and external/internal customers' needs.

Required Skills and Qualifications

  • Extensive experience in Quality Assurance, preferably in a pharmaceutical or related industry.
  • Strong understanding of GMP regulations and quality standards.
  • Excellent communication, leadership, and problem-solving skills.
  • Able to work effectively in a team environment.
  • Proficient in MS Office, particularly Excel, Word, and PowerPoint.
  • Familiarity with document control systems and auditing procedures.

Benefits

  • Competitive salary and benefits package.
  • Opportunities for career growth and professional development.
  • Collaborative and dynamic work environment.
  • Recognition and rewards for outstanding performance.

Others

  • Position is open until filled.
  • Applicants must be authorized to work in the specified country.
  • Equal employment opportunities are offered without regard to race, color, religion, sex, national origin, age, disability, or any other protected characteristic.

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