Denis Chem Lab Assistant Manager - QA Interview Questions and Answers

The life cycle of change control involves planning, implementing, reviewing, and approving changes to a system or process.

• Planning: Identify the need for change and create a plan.

• Implementation: Make the necessary changes and document them.

• Review: Evaluate the effectiveness of the changes and identify any issues.

• Approval: Obtain approval from stakeholders before implementing the changes.

• Examples: Updating software, cha...read more

Artwork should be checked for accuracy and compliance with regulations.

• Verify all text is accurate and matches the approved copy

• Ensure all required elements are present and in the correct location

• Check for proper color usage and consistency

• Confirm compliance with regulatory requirements

• Perform a final proofread for any errors or inconsistencies

Guidelines for QMS, change control, stability, artwork etc.

• QMS guidelines should cover all aspects of quality management, including documentation, training, and audits.

• Change control guidelines should outline the process for making changes to products or processes, including documentation and approval requirements.

• Stability guidelines should cover the testing and monitoring of product stability over time, including sto...read more

The manufacturing process involved multiple stages including raw material procurement, quality checks, production, packaging, and final inspection.

• Raw material procurement from approved vendors

• Quality checks at every stage of production

• Production process involved mixing, blending, and filling

• Packaging of finished products in appropriate containers

• Final inspection to ensure product meets quality standards