As the APAC Recruitment Consultant of the largest dedicated Global Life Science and Pharmaceutical search firm – Barrington James, I am a part of a search team that appoints Senior Professionals in areas such as Quality Assurance and Quality Control.
Since taking over the Quality Desk in Barrington James, I have placed senior Quality professionals across GMP, GDP and GLP in the Pharmaceutical, Biotechnology, and Medical Device industries.
Amidst the pandemic in 2020, I have found an additional niche area in networking with and placing Senior Lab Managers and Lab Managers to aid Molecular Diagnostics laboratories in accrediting and setting up their COVID-19 testing capabilities.
What defines Quality Assurance in Life Sciences?
Quality Assurance is an integral and pivotal part of any organisation; even more so, in the Life Science industry, where compliance and stringency regarding standards of drugs or medical devices are crucial in the continued success of the company, and more importantly, the patient or consumer’s health.
Quality Assurance is a pro-active approach, not a reactive action.
Quality Assurance covers a broad range of functions, including but not restricted to corporate and governance compliance, verification and validation, GxP compliance (manufacturing, distribution, laboratory, clinical, etc.), computer systems validation, TPM, design quality and supplier quality engineering.
Adhering to compliance and upholding Quality standards often a time comes with its fair share of challenges. To be in QA is to safeguard public health so there is a distinct purpose in the job. However, on the other hand, QA may also be misunderstood as a “police-snubbing-the-thief” function.
In certain circumstances, QA is incorrectly viewed as a “hindrance” in the process. This not only makes the QA personnel’s work inopportune; it also slows down the process and therefore imposes a negative effect on the process’s efficiency.
What makes Quality a valuable function in a manufacturing business?
Quality is not only valuable in a manufacturing business; it is also a dynamic and essential function. This is because consistently upheld quality standards ensure that preventable deviations are kept to absolute minimum in the manufacturing business. In addition, non-compliances can be fixed easier at its infancy stage, before the product is manufactured in bulk. This proves the importance of corrective and prevention actions (CAPA) following proactive audits.
In the event that a product defect is discovered only after it has been manufactured in bulk, this will lead to product recalls, which leads to the company losing money, thus there will be a loss instead of profit generated, which then results in an adverse and undesirable reaction.
What makes Quality a valuable function in a commercial business?
In a distribution business, upholding Quality standards helps to protect the company’s brand name in the market. This in turn helps to generate greater revenue, which is the ultimate end goal for all commercial businesses.
What are the challenges that a company faces when the Quality function is not highly valued?
If the Quality function is not highly regarded in a business, a lack of adherence and compliance to stringency in products’ safety and regulatory standards may prevail.
Quality folks, though resilient and decisive, could feel under-appreciated in their job roles, which could affect staff morale and staff retention rates.
Conclusion and sentiments
Overall, upholding Quality standards should be governed proactively by all the building blocks and departments in the business, and not relied solely on the Quality function alone. In this way, the Quality function will be more empowered in preventing and minimalising mistakes and defects in manufactured products, and to avoid problems when delivering products or services to consumers.
If you require assistance placing senior Quality professionals across GMP, GDP and GLP in the Pharmaceutical, Biotechnology, and Medical Device industries, connect with and contact WanYun Nie – email@example.com