Quality Assurance Trainee

JOB DETAILS:

JOB PURPOSE:

The Quality Assurance Trainee plays a crucial role in supporting the Quality Assurance Supervisor in maintaining product quality, safety, and compliance with regulatory requirements. He/ She is responsible for performing day-to-day quality assurance activities, conducting inspections, and the implementation of quality systems and procedures.

The Quality Assurance Trainee also works closely with cross-functional departments to ensure that all aspects of manufacturing processes adhere to current Good Manufacturing Practices (cGMP) and other relevant standards.

KEY RESPONSIBILITIES:

Inspection and Quality Control:

• Conduct regular inspections of manufacturing processes, equipment, and facilities to ensure compliance with quality standards and cGMP requirements.
• Review batch records, test results, and other quality-related documentation for accuracy and completeness.

Non-Conformance Management:

• Conduct thorough investigations and propose relevant resolutions of non-conformances, deviations, and out-of-specification results.
• Collaborate with the cross-functional team to implement appropriate corrective and preventive actions (CAPAs) to prevent recurrence.

Document Control:

• Development and implementation of Quality Assurance Standard Operating Procedures (SOPs), validation protocols, etc.
• Ensure proper issuance, retrieval, and storage of quality-related documents in the organization.
• Support the maintenance and control of quality-related documents, including Standard Operating Procedures (SOPs), records, and validation protocols.
• Ensure that documentation complies with data integrity and version control requirements.

Training and Development:

• Provide training and guidance to personnel on quality procedures and compliance with cGMP standards.
• Assist in developing training materials and conducting training sessions as needed.

Audits and Inspections.

• Participate in internal and external audits, assisting in the preparation and response to audit findings.
• Collaborate with the cross-functional team to address audit observations and implement necessary improvements.

Continuous Improvement:

• Identify opportunities for process improvements and efficiency enhancements in quality assurance activities.
• Work with cross-functional teams to implement best practices and quality enhancements.

Batch Release Support:

• Assist in the batch release process, ensuring that the finished products meet all quality specifications before release for distribution.

Supplier Quality Management:

• Collaborate with the procurement team to perform supplier audits and evaluations to ensure the quality of raw and packaging materials.

Qualification, validation, verification, and shopfloor activities:

• Plan, support, execute and document all planned and unplanned qualifications, validations, and verifications in coordination with cross-functional team.
• Perform in-process quality control tests and other activities required of QA in Manufacturing, Warehouse, Quality Control and Engineering departments.

MINIMUM POSITION QUALIFICATION REQUIREMENTS:

Academic & Professional:

Experience: