Job Title: Quality Assurance (QA) Engineer
Experience Required: 3-4 years
Job Overview:
We are seeking a highly motivated and detail-oriented Quality Assurance (QA) Engineer to join our pharmaceutical team. The QA Engineer will ensure that all products and processes meet rigorous industry quality standards and regulatory requirements. The role involves working closely with manufacturing, validation, and regulatory teams to implement and monitor quality systems in a GMP-regulated environment.
Key Responsibilities:
- Quality Management Systems (QMS): Maintain and improve the QMS to ensure compliance with FDA, GMP, and other regulatory standards.
- Document Control: Manage the documentation process, including SOPs, batch records, and quality reports, ensuring all documents meet regulatory and company standards.
- Auditing: Conduct internal audits of manufacturing processes, procedures, and documentation to ensure compliance with GMP and regulatory requirements.
- CAPA Management: Identify non-conformances and deviations, lead root cause analysis, and develop corrective and preventive actions (CAPAs) to improve product and process quality.
- Change Control: Support and monitor change control processes for manufacturing, equipment, and processes to ensure continuous quality compliance.
- Risk Management: Implement and monitor risk management protocols in line with FDA and ICH Q9 guidelines to minimize quality issues during production.
- Supplier Quality Management: Coordinate with suppliers and third-party vendors to ensure raw materials and components meet predefined quality standards.
- Product Testing: Review and approve product testing protocols, analyze data, and ensure that products meet release specifications.
- Training and Development: Provide training to staff on quality policies, SOPs, and compliance requirements to foster a culture of continuous quality improvement.
- Regulatory Compliance: Collaborate with regulatory affairs to prepare for inspections and audits by regulatory authorities such as the FDA and EMA.
Qualifications:
- Experience: 3-4 years of quality assurance experience in a pharmaceutical or biotech environment.
- Education: Bachelor’s degree in Quality Engineering, Pharmaceutical Sciences, Chemistry, or a related field.
- Regulatory Knowledge: Strong understanding of FDA regulations, cGMP, ICH guidelines, and 21 CFR Part 11 compliance.
- Technical Skills:
- Proficient in using QMS software.
- Experience with root cause analysis, CAPA management, and risk assessments.
- Familiar with batch record review, validation processes, and auditing procedures.
- Problem-Solving: Excellent analytical and problem-solving skills, with a focus on driving continuous quality improvements.
- Communication: Strong communication and documentation skills, with the ability to collaborate with cross-functional teams and ensure regulatory standards are met.