Quality Manufacturing

Main

Duties

May vary from

One company to another

Releases lots: approves manufacturing and packaging master files; review batch records for manufacturing, packaging, and deviation; ensures documents are in compliance; releases or rejected lots of raw materials, and finished products intended for retail; assesses product returned.

Evolution of the Profession

Among other things, more sophisticated computer systems facilitate data traceability and availability, parallel as opposed to serial assessments, and the integration of different computerized systems to allow for :

Ensures that customer complaints are handled: analyzes customer non-medical complaints; identifies trends and tendencies with respect to lot, product, and type of complaint and determines the cause; recommends changes based on investigation and trend analyses.

Manages control of changes: helps evaluate change requests for equipment, primary and secondary components, processes, closes changes upon implementation.

Involved in activities geared towards procedural improvements and documents approval: review and approves product quality failure and non-compliance investigation; performs follow-up on correction and preventive action pursuant to an incident; reviews standard operating procedure; assists with internal and external audits.

Participates in the annual product review : review documents related to the products; complies trend-analysis data and writes a trend-analysis report.

an overview of quality systems such as procedures, CAPAs, investigation, and control changeover;

trend reviews and more efficient monitoring;

Improved documents control and approval times.

Regulatory agencies and the FDA focus on investigation, control of changes, complaints, cross contamination, CAPAs, and risk management.

Companies must document all decisions and deviations pertaining to correction and preventive action to avoid recurrences.

Best Practices

Upgrade knowledge in order to remain proficient in the profession.

Attend continuing-education and development activities.

Main responsibilities

Lot Release

Carefully review and approves product manufacturing and packaging batch files.

Properly verifies document completion and compliance.

Adheres to standard, procedure, and quality agreements.

Issues appropriate certificates.

Properly assesses the need to perform laboratory tests.

Change Management

Helps evaluate change requests for equipment, primary and secondary components, processes, and various types of documents.

Properly manages priorities according to deadlines.

Obtained evaluation with support documents from concerned departments.

Fairly assesses the impact of changes on the organization.

Complies with controlled documents.

Approves changes implementations.

Ensures completion and/or monitoring of all identified regulatory activities.

Procedure Improvement and Document Approval Activities

Activity assists in investigation into product-quality failure or non-compliance.

Uses support documents to thoroughly review and approve investigations.

Effectively manages priorities in order to implement correction and preventive actions.

Correctly applies CAPAs or changes management.

Approves and ensures implementation of standardized operating procedure.

Approves documents according to templates and required GMPs.

Provides inspectors with clear and comprehensive files (external audits).

Responds with proficiency to question from inspectors (external and internal audits).

Activity engaged in the follow-up of audit observation.

Qualification

Quality-Assurance Officer have:

A bachelor of chemistry

A master’s degree industrial chemistry

Competencies

Leadership

Communication clearly and effectively.

Correctly evaluates the facts and unforeseen situation in order to make the best decisions.

Makes decisions within a regulatory context.

Document Management

Cautiously analyzes data.

Verifies document completion for compliance with standards and specifications for pharmaceutical products.

Drafts reports within prescribed time frames and in accordance with regulations.

Approves required certificates.

Problem Solving

Adopts a rigorous approach to problem solving within a regulatory context.

Adapts to unforeseen situations.

Assesses the urgency of situations.

Follow up on compliance issues until final resolution.

Quality Assurance

Is very proficient with regulatory requirements and good manufacturing practices.

Rigorously monitors compliance with good manufacturing practices, regulatory requirements, and company and industry standards.

Judiciously identifies non-compliance situations.

Proposes realistic and relevant actions.

Ensures product integrity and compliance based on standard and regulations.

Complies with established timelines.

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