Pharmaceutical quality specialist

Pharmaceutical quality specialists perform inspections and precision measurements in order to test and ensure the quality of pharmaceutical products. They are involved in the whole development phase of a pharmaceutical product until it is ready for the market. This includes the process of acquiring clinical trial licences, advising the pharmaceutical development staff on regulatory requirements and evaluating the content of the package leaflet and other documentation on the product. Moreover, pharmaceutical quality specialists collect and evaluate information on side effects of the product and communicate this knowledge both internally and to the relevant authorities.

Here are some of the typical duties of pharmaceutical quality specialists:

• Develop and implement quality management systems and standard operating procedures to ensure adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulations and guidelines.
• Conduct internal audits of manufacturing processes, laboratory procedures, and documentation to identify areas for improvement and compliance with quality standards.
• Collaborate with cross-functional teams, including research and development, production, and regulatory affairs, to ensure quality objectives are met at each stage of product development and production.
• Review and approve documentation related to product development, including batch records, analytical testing reports, and validation protocols.
• Monitor and evaluate the performance of pharmaceutical manufacturing processes and equipment to identify and address any deviations or issues that may impact product quality.
• Investigate and resolve quality-related complaints, non-conformances, and deviations to prevent potential product recalls or quality incidents.
• Oversee the validation and qualification of equipment, processes, and analytical methods used in pharmaceutical manufacturing.
• Ensure compliance with Good Distribution Practices (GDP) during the storage and transportation of pharmaceutical products.
• Participate in regulatory inspections and audits from health authorities and external agencies, providing necessary documentation and support to demonstrate compliance with regulations.
• Provide training and education to staff members on quality-related topics, including GMP, GLP, and other quality standards.
• Monitor and stay updated on changes to regulatory requirements and industry best practices related to pharmaceutical quality.
• Collaborate with suppliers and contract manufacturers to ensure the quality of raw materials and finished products used in pharmaceutical manufacturing.
• Participate in risk assessments and implement risk management strategies to prevent quality-related issues.
• Conduct trend analyses and data evaluations to identify patterns and potential areas for improvement in product quality and manufacturing processes.
• Participate in the development and implementation of Corrective and Preventive Actions (CAPAs) to address quality issues and prevent their recurrence.
• Ensure compliance with all relevant safety and environmental regulations within the pharmaceutical manufacturing environment.

The following job titles also refer to pharmaceutical quality specialist:

pharmaceutical quality technician
pharmaceutical quality control specialist
pharmaceutical quality control technician
specialist of pharmaceutical quality compliance
pharmaceutical quality inspector
specialist of pharmaceutical quality control
pharmaceutical quality manager
pharmaceutical product quality manager
pharmaceutical quality compliance specialist
pharmaceutical quality verifier
specialist of pharmaceutical quality

Pharmaceutical quality specialists work in pharmaceutical manufacturing facilities, research laboratories, or quality control departments. They may be required to wear protective clothing, such as lab coats and safety goggles, when working in laboratory settings. The work environment is typically fast-paced, and attention to detail is essential to maintain strict adherence to quality standards and regulatory requirements.

To become a pharmaceutical quality specialist, individuals typically need a bachelor’s or master’s degree in pharmaceutical sciences, chemistry, or a related field. Additional qualifications in quality management or regulatory affairs are beneficial. Experience in pharmaceutical manufacturing, quality control, or quality assurance is highly valued. Continuous professional development and training are essential to stay current with evolving regulations and best practices in pharmaceutical quality.

ISCO skill level is defined as a function of the complexity and range of tasks and duties to be performed in an occupation. It is measured on a scale from 1 to 4, with 1 the lowest level and 4 the highest, by considering:

• the nature of the work performed in an occupation in relation to the characteristic tasks and duties
• the level of formal education required for competent performance of the tasks and duties involved and
• the amount of informal on-the-job training and/or previous experience in a related occupation required for competent performance of these tasks and duties.

Pharmaceutical quality specialist is a Skill level 4 occupation.

These occupations, although different, require a lot of knowledge and skills similar to pharmaceutical quality specialist.

pharmacologist
analytical chemist
assayer
biochemist
nanoengineer

This knowledge should be acquired through learning to fulfill the role of pharmaceutical quality specialist.

• Pharmaceutical legislation: European and national legal framework for the development, distribution, and use of medicinal products for humans.
• Pharmaceutical products: The offered pharmaceutical products, their functionalities, properties and legal and regulatory requirements.
• Analytical chemistry: Instruments and methods used to separate, identify and quanitfy matter – the chemical components of natural and artificial materials and solutions.
• Controlled substances permits: The legal requirements and licenses required when handling controlled substances.
• Biotechnology: The technology that uses, modifies or harnesses biological systems, organisms and cellular components to develop new technologies and products for specific uses.
• Pharmaceutical technology: Pharmaceutical technology is the branch of pharmaceutics which deals with the technological design, development, manufacture, and evaluation of drugs and medicinal products.
• Laboratory techniques: Techniques applied in the different fields of natural science in order to obtain experimental data such as gravimetric analysis, gas chromatography, electronic or thermic methods.
• Pharmaceutical industry: The main stakeholders, companies and procedures in the pharmaceutical industry and the laws and regulations that govern the patenting, testing, safety and marketing of drugs.
• Pharmaceutical chemistry: The chemical aspects of identification and synthetic alteration of chemical entities as they relate to therapeutic use. The way various chemicals affect biological systems and how they can be integrated in drug development.

These skills are necessary for the role of pharmaceutical quality specialist.

• Perform product testing: Test processed workpieces or products for basic faults.
• Monitor manufacturing quality standards: Monitor quality standards in manufacturing and finishing process.
• Work analytically: Analyse information flows to reconstruct messages quickly and precisely. Navigate a language to explain the same sense or feeling in situations where there is no definite word or literal translation.
• Work safely with chemicals: Take the necessary precautions for storing, using and disposing chemical products.

This knowledge is sometimes, but not always, required for the role of pharmaceutical quality specialist. However, mastering this knowledge allows you to have more opportunities for career development.

• Chemical products: The offered chemical products, their functionalities, properties and legal and regulatory requirements.
• Pharmacology: Pharmacology is a medical specialty mentioned in the EU Directive 2005/36/EC.
• Chemical processes: The relevant chemical processes used in manufacture, such as purification, seperation, emulgation and dispergation processing.
• Basic chemicals: The production and characteristisc of organic basic chemicals such as ethanol, methanol, benzene and inorganic basic chemicals such as oxygen, nitrogen, hydrogen.

These skills and competences are sometimes, but not always, required for the role of pharmaceutical quality specialist. However, mastering these skills and competences allows you to have more opportunities for career development.

• Record test data: Record data which has been identified specifically during preceding tests in order to verify that outputs of the test produce specific results or to review the reaction of the subject under exceptional or unusual input.
• Transfer chemicals: Transfer the chemical mixture from the mixing tank to the storage tank by turning on the valves.
• Perform chemical experiments: Perform chemical experiments with the aim of testing various products and substances in order to draw conclusions in terms of product viability and replicability.
• Record data from biomedical tests: Use information technology to accurately record and analyse data from biomedical tests, writing reports on the data and sharing results with the appropriate persons.

2262 – Pharmacists

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References

1. Pharmaceutical quality specialist – ESCO
2. Featured image: Photo by James Paul on Unsplash