How to Transition from QC to QA in the Pharmaceutical Industry
Transitioning from Quality Control (QC) to Quality Assurance (QA) in the pharmaceutical industry requires careful planning and acquiring additional skills and knowledge. Many people have asked me how to make that transition as they land their first role inside QC and are looking for their next role outside of QC. Here is a step-by-step guide on how to make this transition:
Understand the Difference between QC and QA
Gain a thorough understanding of the differences between QC and QA roles. QC focuses on testing and analysis of samples to ensure compliance with established specifications, while QA is responsible for establishing and maintaining quality systems, ensuring compliance with regulations, and overseeing the overall quality management process. Being able to understand the difference between the two functions is vital as you will need to be able to articulate to potential QA hiring managers why exactly you want to move away from QC. Many QC specialists that I have worked with in the past have expressed a desire to work in QA and when asking their knowledge of CAPAs, Deviations, Change Controls etc, they were not able to talk about these. At this point in your transition, you are not expected to know how to do these activities but to at least have an understanding of what they are and how they differ from typical QC activites.
Expand Knowledge and Skills in QA
Identify the specific knowledge and skills required for a QA role that may not be covered in your current QC position. This could include regulatory affairs, quality management systems (QMS), risk management, validation, auditing, and compliance. Seek opportunities to learn and develop these areas through training programs, workshops, certifications, or online courses. Often your direct manager will be grateful that you will help them out with additional responsibilities. Use this as a way to gain further training and skills in QA. I have spoke at length the value of networking in many of my articles and will be talking about this specifically in rwh next section. But the reason why it’s important here is because you don’t know what you don’t know. By deliberatly looking to expand your understanding of QA activities, you will be well on your way to prooving your expertise in QA.
Networking and Mentoring with QA Professionals
Connect with professionals already working in QA roles. Attend industry conferences, seminars, or networking events to build relationships and seek guidance from experienced QA professionals. A mentor in the QA field can provide valuable insights and advice on making the transition. I have discussed in this article here about how to plan your career within pharmaceuticals and this can be a useful blueprint for your planning. Check it out if you want to find out more. Networking is extremely important if you want to develop your career. In many cultures, it’s about who you know rather than what you know. In Ireland, this is even more the case and being able to connect with people is massively beneficial to your career. By making sure that you are engaging within QA circles, you will be on the forefront of a QA hiring managers mind when they are looking to add to their team.
Self-Assessment
Evaluate your current skills, strengths, and weaknesses. Identify any gaps between your existing qualifications and the requirements of a QA position. Develop a plan to acquire the necessary skills and knowledge to bridge those gaps. Having done the previous steps, you will have more of an idea of what skills you will need to develop further. This is also important from a longstanding career point of view. I always recommend to my own clients to update their CV/Resumes about every 3-6 months so that they can keep on track of where they want to be in their career. By continuously assessing where you are in your career, you can make sure that you are making the best decisions with regards to your career. In this case this can lead to making sure that you take on specific tasks for “free” in order to gain experience without getting a load of extra work dumped on your plate with no added benefit. Which leads me to…
Take on Additional Responsibilities Within QA
Seek opportunities within your current QC role to take on additional responsibilities related to quality assurance. This could involve participating in investigations, contributing to SOP development, assisting in internal audits, or collaborating with QA personnel on quality improvement projects. These experiences will provide valuable exposure to QA responsibilities. Again speak with colleagues who are doing the activities that you want to be exposed to and see if you can get training in on their duties. I would highly advise you be very selective in what you take on additionally as the last thing you want is find yourself being burnt out and not only letting your new responsibilities suffer but your current ones too, which can put your current role at risk. This is why it’s so important to do the research first before looking to take on additional responsibilities in QA.
Gain Regulatory Knowledge Specific for QA
Familiarise yourself with relevant regulatory guidelines and requirements governing the pharmaceutical industry, such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP). Understand how these regulations impact QA functions and learn to interpret and apply them effectively. This means taking it beyond the lab, often we are focused on doing the steps to ensure complience, but we don’t really think about why we are doing that. If you are looking to step into a more QA orientated role, you will need to take a bigger picture look at the why.
Obtain Certifications for QA
Pursue certifications relevant to QA in the pharmaceutical industry, such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Certified Pharmaceutical GMP Professional (CPGP). These certifications demonstrate your commitment to quality and validate your knowledge and expertise in QA. Personally I believe that industry experience can trump academic qualifications and so I would always recommend trying to get trained on the job, however everyone has a different path and so it’s good to be aware of this as an option. This path can be good for people who can’t get the additional responsibilities for one reason or another in their current role and can offer an alternative route.
Seek Internal Opportunities for QA
Once you have a solid grasp on what is to be expected from working in a QA role, explore opportunities within your current organisation to transition into a QA role. Express your interest to management and HR personnel, and make them aware of your career aspirations. Consider applying for internal QA job postings or projects that involve QA-related tasks. There would be less of a risk for your employer to hire you in a QA role as you would have a track record from working with them before. And as I have said before, people hire people that they like. Increase your influence and work on your networking skills and you will find yourself in a more favourable position.
Update Your Resume/CV
Tailor your resume/CV to highlight relevant skills, knowledge, and experiences that demonstrate your readiness for a QA role. Emphasise your contributions to quality improvement, compliance-related activities, and any relevant certifications or training you have acquired. Make sure to highlight your knowledge of what a QA specialist would be doing, what activities you have been doing in your QC role to support that and to have a strong opening statement on your CV/resume to explain why you are motivated to transition from QC to QA. And if you want a professional to help you with this transition, feel free to check my availability and book a consultation with me.
Job Search for QA Opportunities
Begin actively searching for QA job opportunities in the pharmaceutical industry. You should now have a fairly strong network of QA people that you have been talking to throughout this process. Make sure to leverage your network, professional connections, and online job portals to find openings. Prepare for interviews by familiarising yourself with common QA-related interview questions and articulating how your QC experience has prepared you for a QA role. If you are looking for a more comprehensive article on how to actually start your job search in pharamaceuticals, make sure to check out this article here.
Continuous Learning
Once you transition into a QA role, commit to continuous learning and professional development. Stay updated with regulatory changes, industry trends, and advancements in quality management systems. Participate in workshops, conferences, and webinars to enhance your skills and knowledge in QA. Many people go onto many different fields within QA so it’s certainly a road full of exctiment!
Remember, transitioning from QC to QA requires a combination of acquiring new knowledge and skills, gaining practical experience, networking, and demonstrating your commitment to quality. Be patient, persistent, and proactive in pursuing opportunities and continuously improving yourself as a quality professional.
Best of luck!
