Quality Assurance in the Pharmaceutical Industry
Quality in the Pharmaceutical industry is defined as products that are safe for intended use, are effective and meet patient expectations. In order to consistently deliver products that meet quality standards, Good Manufacturing Practices (GMP) must be in place spanning all parts of the process including materials, equipment, facilities, research as well as ensuring your staff has been properly trained. A knowledgeable and efficient individual or team of Quality Assurance employees is key to this process running smoothly. Let’s take a closer look at these roles:
Quality Assurance
Quality Assurance professionals are responsible for the step-by-step process of ensuring goods and services meet specific quality, efficacy and safety requirements, as per their intended use. Some key examples of their role are:
- Assuring healthcare professionals, the product prescribed has the correct efficacy.
- Protecting the public from harm that could be caused by: design defects, manufacturing errors, problems from packaging or storage and incorrect instructions.
- Making sure all products comply with industry regulations, laws and guidelines.
What does the Quality Assurance Team Do?
The QA team is involved in every step of the process. This means they play a hand in the entire product lifecycle from development to manufacturing with a varied set of job responsibilities. Some of these tasks could include:
- Checking raw materials, equipment, vendors & testing methods during the development stage
- Preparing and monitoring documentation
- Developing measurement parameters for quality
- Ensuring employees are trained on protocols & processes and training documentation is up to date
- Logging and addressing any customer complaints or product issues
- Investigating any issues that stem from customer complaints
- Conducting internal audits on documentation, processes, training and equipment
- Driving continuous improvement to make sure manufacturing processes are maintained and optimized
- Writing company Standard Operating Procedures (SOP)
What are the Job Qualifications?
For an entry-level position in Quality Assurance the typical requirements would be a Bachelor’s degree in science or technology, with great organizational and analytical skills. As you look for roles with greater responsibility within QA, several years of experience would be required. There are also a multitude of certifications you can complete related to these roles that would give you the information needed to set yourself apart from other applicants and excel in these positions.
What are some Possible Job Roles?
- Quality Assurance/Control Associate
- Quality Assurance Technician
- Documentation Specialist
- Quality Analyst
- Quality Engineer
- Quality Assurance Manager/Director
Applying for Current Openings
Our team at PharmaOut works regularly to place Quality Assurance professionals with our company partners. If you are interested in a QA role please fill out this form, and one of our recruiters will get in touch with you to discuss current openings or possible future positions.
We look forward to working with you!
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