Senior Quality Assurance Manager

5 days ago

Bikaner, Rajasthan, India beBeeQuality Full time ₹ 10,00,000 - ₹ 15,00,000

Job Title: Senior Quality Assurance Manager

This is a key leadership role within the company, responsible for ensuring compliance with all regulatory requirements and maintaining a robust quality management system.

Job Description
  • Lead and manage the development and implementation of quality systems, policies, and procedures across the organization.
  • Coordinate and conduct audits, including vendor qualification activities, to ensure compliance with regulations and standards.
  • Develop and maintain a GMP compliant document control system and establish a robust Quality Management System (QMS) to manage change, deviations, incidents, complaints, and CAPA management.
  • Provide quality guidance to product development projects and programs, and ensure that all validation activities are carried out according to approved protocols and requirements.
  • Maintain and improve departmental operational performance to meet regulatory requirements, SOPs, and customer expectations regarding quality, service, lead time, and cost.
Required Skills and Qualifications
  • Strong leadership and management skills, with experience in leading cross-functional teams.
  • Excellent communication and interpersonal skills, with the ability to build relationships with stakeholders at all levels.
  • Proven track record of implementing and maintaining quality systems, policies, and procedures.
  • Knowledge of regulatory requirements, including cGMP, EU GMP, PIC/S, and MHRA.
  • Ability to analyze data and make informed decisions.
Benefits

The successful candidate will have the opportunity to work in a dynamic and challenging environment, with a competitive salary and benefits package.

Others

Other responsibilities may include:

  • Reviewing and approving documents, including Batch Manufacturing Records and Batch Packaging Records.
  • Coordinating and conducting internal audits and inspections.
  • Maintaining and improving the Quality Review Meetings and Management Review Meetings processes.
  • Ensuring adherence to the Validation Master Plan and schedule.

Tech Requirements:
Qualifications in pharmaceutical science or related field; experienced professional with knowledge of international quality and regulatory requirements.

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