Duties and responsibilities of QA person in Pharma Industry

A QA person in the pharmaceutical industry plays a crucial role in ensuring that products meet the required quality standards.

Rakesh Dahiya

February 28, 2023

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Rakesh Dahiya

SDCO Cum Licensing Authority |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com

Quality assurance

Quality assurance (QA) plays a critical role in ensuring that pharmaceutical products meet the required quality standards.

In the pharmaceutical industry, a QA person is responsible for ensuring that products are manufactured, tested, and released according to the relevant regulations and guidelines.

This article will cover the qualifications, duties, and responsibilities of a QA person in the pharmaceutical industry.

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Qualifications of a QA Person

To become a QA person in the pharmaceutical industry, one should have a degree in a science-related field, such as chemistry, biology, or pharmacy, to better understand pharmaceutical products.

Some employers may also require additional qualifications or training in quality management systems or as per regulatory requirements.

In addition to formal education, a QA person must have attention to detail, excellent communication and interpersonal skills, and the ability to work well in a team.

They must be familiar with regulatory requirements and industry guidelines, as well as quality management systems and statistical analysis.

Duties and Responsibilities of a QA Person

QA person in a pharmaceutical industry should perform primarily the following duties and responsibilities:

Review of Manufacturing Processes: The QA person ensures that manufacturing processes meet the required quality standards by reviewing the manufacturing procedures, batch records, and testing protocols.
Product Release: A QA person ensures that products are released only after they have met the required specifications and are deemed safe and effective.
Quality Control: A QA person collaborates with the Quality Control (QC) team to ensure that laboratory testing is conducted appropriately and meets the required specifications.
Audit: The QA person conducts regular internal audits of the manufacturing facility to ensure that the facility meets the required quality standards. Also handles the external audit cand its compliance.
Documentation: A QA person is responsible for ensuring that all necessary documentation is completed accurately, in a timely manner, and in compliance with regulatory requirements.

Deviation Management: The QA person is responsible for reviewing and approving deviation reports and ensuring that corrective and preventive actions (CAPA) are implemented.
Complaint Handling: The QA person is responsible for reviewing and investigating product complaints to ensure implementation of corrective and preventive actions (CAPA).
Product recall: The QA person is responsible for reviewing and investigating product which are called back due to some defects in the products and ensure implementation of root cause analysis (RCA) and corrective and preventive actions (CAPA).
Training: A QA person is responsible for training of manufacturing and laboratory personnel on quality-related procedures and regulations.

Apart from the above the QA person in a pharmaceutical industry should also perform the following duties and responsibilities:

Quality management system: Handling of quality management system (Change Control system, Deviation, Incident & other related documents).
Laboratory incidents: Handling of out of specification (OOS) and out of trend (OOT) laboratory incidents and their closing.
Quality control: Preparation & review the method of analysis (MOA), standard testing procedure (STP) and other documents related to QC.
Non-conformity: Handling of non-conformity as per defined procedure.
SOPs: Preparation & implementation of SOPs related to the concerned department.
BPR: Implementation & verification, in-process checks, online entries in BPR of product at manufacturing site.
GMP: Monitoring and ensuring the good manufacturing practice (GMP) at manufacturing site.
GLP: Monitoring and ensuring the good laboratory practice (GLP) by laboratory personal during the routine analysis and instrument operation ensure adherence to procedure.
Quality Risk Assessment: Preparation & review of Quality Risk Assessment.

Line clearance: To give line clearance before starting the new batch in production.
Sampling: Sampling the intermediate, semi-finish & finish of product.
Raw material: To verify dispensing of raw material.
Temperature & humidity: Monitoring the record of Temperature & Relative Humidity in respective areas.
Product specifications: Develops, implements, and manages processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery.
Standard for products: Identifies and sets appropriate quality standards and parameters for products.
New technologies: Evaluate new technologies and methods to make recommendations regarding their use.
Other documentation: To prepare the Validation Master Plan, Site Master File, Drug Master File, Annual Product Quality Review, Plant Layout and other documents related to QA.
Customer: To execute and providing the Documents to Customers.

Conclusion

A QA person in the pharmaceutical industry plays a crucial role in ensuring that products meet the required quality standards.

The responsibilities of a QA person include reviewing manufacturing processes, product release, quality control, audits, documentation, deviation management, complaint handling, product recall, and training.