A Day in the Life of a Quality Assurance Specialist in the Pharmaceuticals World
The pharmaceutical and life sciences industry is a fast-growing and dynamic field, with a combined worth of approximately $2.83 trillion. This growth has been further accelerated by the demand for products during the COVID-19 pandemic, particularly vaccines. Life sciences companies are adapting to this evolving landscape through acquisitions, divestitures, investments in research and development (R&D), and the integration of digital and data technologies. The role of Quality Assurance is represented through holding these processes and products at the highest possible standard.
More than 300 drugs and medical devices have been recalled since 2021 which is a large cost for both companies and patients. This is being addressed with a newly risen approach, a product of the digital transformation, Quality 4.0. This approach leverages traditional quality assurance methods with emerging Industry 4.0 technologies – Internet of Things (IoT), artificial intelligence (AI), big data analytics, and automation. In this blog post, we will delve into the daily routine of a Quality Assurance Specialist within the current pharmaceuticals world, shedding light on their pivotal role in maintaining the highest standards of quality.
Quality Assurance Specialists in the pharmaceutical’s world can be found in various locations, including pharmaceutical manufacturing facilities, research and development labs, and corporate offices. Their work may also involve travel to conduct inspections, audits, or attend industry events and training.
A typical day for a Quality Assurance Specialist begins with a review of essential documents, such as Standard Operating Procedures (SOPs), batch records, and validation protocols. These documents outline the standards and processes to be followed. The day often involves cross-functional meetings with production, R&D, and regulatory affairs teams to align on quality objectives and ongoing projects. Preparing for internal audits or regulatory inspections is a critical aspect of their schedule. This entails ensuring that all records and documentation are in order and up to date. Staying updated with industry regulations and advancements may require attending training sessions or workshops.
Key Responsibilities of a Quality Assurance Specialist
Quality assurance is paramount in the life science industry to ensure the safety and efficacy of pharmaceuticals, medical devices, and other healthcare products. Quality Assurance Specialists play a vital role in overseeing and implementing quality control processes. Their responsibilities encompass a wide range of tasks aimed at ensuring that products are manufactured, tested, and distributed in strict adherence to regulatory requirements.
Quality Assurance Specialists perform physical inspections of products and production processes, including equipment, materials, and finished products, to ensure compliance with quality standards. They utilise statistical tools and software to analyse quality data, track trends, and identify areas for improvement. Ensuring that all records are accurate and up to date is essential.
They meticulously maintain records to demonstrate compliance with regulatory standards. When quality issues arise, Quality Assurance Specialists collaborate with other teams to identify the root causes and implement corrective and preventive actions (CAPA).
Addressing non-conformities is a critical aspect of their role. They investigate any deviations from quality standards and work to resolve them promptly. Quality Assurance Specialists continuously work to maintain certifications and ensure products meet all regulatory requirements. Actively seeking ways to enhance processes, making them more efficient and compliant, is a central part of their role. This involves continuous improvement initiatives and feedback loops.
Quality Assurance Specialists in the pharmaceutical’s world require a diverse set of soft skills, including:
- Attention to detail
- Analytical thinking
- Strong communication skills
- Knowledge of industry regulations
- Proficiency in statistical analysis
- Problem-solving abilities
- Adaptability to changing regulations and technologies
More technical skills involve:
- GAP analysis
- Quality Risk Management
- Performing internal audits
- OOS investigations
- General management of change and control systems
Life Science Careers at Quanta
Here at Quanta part of QCS Staffing, we provide a specialist recruitment service and often have Quality Assurance roles within our Life Science Sector. For information on the steps to become a Quality Assurance Specialist, find out how to become a quality assurance specialist. The world of Quality Assurance is dynamic and rewarding, offering a chance to contribute significantly to the success of projects and the satisfaction of end-users. If this is the role for you, contact us now to receive immediate response from one of our consultants.