Job Description

As a Quality Assurance (QA) Specialist in the pharmaceutical industry, your role is pivotal in ensuring that pharmaceutical products meet regulatory requirements, industry standards, and internal quality specifications. You will be responsible for implementing quality assurance processes, conducting audits, and overseeing compliance with Good Manufacturing Practices (GMP) and other relevant regulations. Attention to detail, regulatory knowledge, and a commitment to upholding product quality and safety are essential for success in this role.

Key Responsibilities:

1. Quality System Management:

   • Develop, implement, and maintain quality management systems (QMS) to ensure compliance with regulatory requirements such as FDA (Food and Drug Administration) regulations, GMP, and ICH (International Council for Harmonisation) guidelines.
   • Establish procedures for document control, change management, deviation management, and CAPA (Corrective and Preventive Actions) processes.

2. Quality Audits and Inspections:

   • Plan and conduct internal quality audits to assess compliance with company policies, procedures, and regulatory requirements.
   • Prepare for and support regulatory inspections and customer audits by ensuring documentation readiness and providing necessary support and guidance to auditors.

3. Batch Release and Product Review:

   • Review batch documentation, analytical data, and manufacturing records to ensure compliance with established specifications and regulatory requirements.
   • Participate in the release of finished products by assessing batch records, certificates of analysis, and other relevant documentation.

4. Quality Training and Continuous Improvement:

   • Develop and deliver training programs to ensure employees understand and adhere to quality standards, procedures, and regulatory requirements.
   • Identify opportunities for process improvements and drive initiatives to enhance quality, efficiency, and compliance within the organization.

5. Change Control and Validation:

   • Review and approve change control requests related to manufacturing processes, equipment, facilities, and documentation.
   • Support validation activities for equipment, processes, and systems to ensure compliance with regulatory requirements and industry best practices.

Skills Required

• MS Excel