Quality Control Trainee

JOB DETAILS:

JOB PURPOSE:

The Quality Control Trainee is primarily responsible for performing a wide range of quality control tests and analyses on raw materials, bulk samples, validation samples, and finished products while ensuring compliance with Good Manufacturing Practices (GMP) and maintaining the quality and safety of products.

KEY RESPONSIBILITIES:

Documentation and Reporting:

• Promptly record all test results, observations, and data accurately.
• Generate analytical reports and documentation to be reviewed and filed in compliance with GLP, relevant regulations and procedures.

Data Integrity:

• Adhere to data integrity principles and ensure all electronic records, including raw data and metadata, are accurately recorded, stored securely, and protected against unauthorized changes.

Quality Compliance.

• Adhere to Good Laboratory Practices (GLP), and other relevant quality and safety regulations during all aspects of work.
• Assist in internal and external audits, and actively participate in implementing corrective and preventive actions (CAPAs).

Training and Development:

• Participate in training sessions to improve knowledge of analytical techniques, compliance requirements, and safety protocols.
• Share knowledge and best practices with other team members to foster a culture of continuous learning.
• Assist in developing training materials and conducting training sessions as needed.

Out-of-Specification (OOS) Investigation:

• Conduct out-of-specification result investigation, root cause analysis, and deviation management and thereafter determine the potential impact on product quality and recommend appropriate corrective actions.

Analytical Method Verification/ Validation:

• Participate in the verification and validation of analytical methods used in the Quality Control laboratory and ensure that these methods are accurate, precise, specific, and robust.

Instrument Qualification:

• Execute instrument qualification activities to ensure that laboratory instruments used in quality control testing are fit for their intended purpose and comply with regulatory requirements.

Instrument Maintenance:

• Perform routine maintenance, calibration, and troubleshooting of laboratory instruments and equipment.
• Collaborate with the Engineering team to ensure that all equipment is in good working condition and in compliance with applicable standards.

Sampling:

• Implement appropriate sampling plans for raw materials, packaging materials, and finished products and ensure that samples are representative and properly labeled, and that they follow defined storage and handling requirements.
• Maintain accurate and up-to-date records of sample information.

Analytical Testing:

• Conduct comprehensive testing and analysis of raw materials, packaging materials, and finished products following established procedures and specifications.

Stability Testing:

• Design and execute stability studies for products according to regulatory guidelines and procedures and stability protocols.
• Monitor and evaluate product stability over time to ensure that the quality and efficacy of products are maintained throughout their shelf life.

Safety and Compliance Culture:

• Promote a culture of safety, quality, and compliance within the manufacturing plant.

Continuous Improvement:

• Contribute to the continuous improvement of quality control processes, methodologies, and systems to enhance efficiency, accuracy, and overall quality standards.

MINIMUM POSITION QUALIFICATION REQUIREMENTS:

1. Academic & Professional:

1. Experience: