Responsibilities in Job
As an Executive in Quality Assurance, you will play a crucial role in maintaining and enhancing the quality standards of Azurity’s products. Your primary responsibilities will include:
- Review of Batch Documentation: Overseeing the batch documentation received from contractor sites to ensure compliance with regulatory standards.
- APQR Preparation and Verification: Preparing and verifying the Annual Product Quality Review (APQR) for executed batches.
- Process Validation Oversight: Reviewing process validation protocols and reports to ensure adherence to established guidelines.
- GMP Compliance: Ensuring that Good Manufacturing Practices (GMPs), Standard Operating Procedures (SOPs), and protocols are followed during batch execution.
- Documentation Certification: Reviewing and certifying protocols related to Chemistry, Manufacturing, and Controls (CMC) for dossier submissions.
- Collaborative Problem-Solving: Positively interacting with internal associates, contractors, and partners to resolve issues promptly and effectively.
- Quality Management System Support: Supporting the implementation of Corrective and Preventive Actions (CAPAs), quality improvement initiatives, and other Quality Management System (QMS) activities.
- SOP Preparation: Assisting in the preparation of standard operating procedures related to Quality Assurance.
Qualifications and Education Requirements
To be considered for the Executive – Quality Assurance position at Azurity Pharmaceuticals, candidates should meet the following qualifications:
- Education: A postgraduate degree in pharmacy with a strong academic background.
- Experience: 3-5 years of industrial experience in a reputable pharmaceutical organization, with a preference for exposure to In-Process Quality Assurance (IPQA) in sterile manufacturing operations.
Skills
The ideal candidate will possess a range of skills and abilities that are essential for success in this role, including:
- Attention to Detail: A keen eye for detail to ensure compliance with quality standards and regulations.
- Problem-Solving Skills: Strong analytical and problem-solving abilities to address issues that arise during the QA process.
- Communication Skills: Excellent verbal and written communication skills for effective collaboration with team members and external partners.
- Technical Proficiency: Familiarity with relevant quality assurance practices, GMPs, and regulatory requirements.
- Adaptability: The ability to adapt to a fast-paced environment and manage multiple tasks simultaneously.
