Joharaltaf

QC Manager

Oct 2020 - Present • 5 yrs 9 mos

Let me tell you what I actually do as a QC Manager. Right now, I oversee the entire quality control lab at CIBEX Pharmaceutical. My job is to make sure every product that leaves our facility is safe, effective, and meets all the regulatory requirements. Here's what my day-to-day looks like: I develop and implement testing protocols. Every raw material that comes in, every in-process sample, every finished product — I make sure we have a clear procedure for testing it. No shortcuts. I oversee the actual testing. I make sure our lab team is following the right methods — whether it's HPLC, dissolution testing, or microbial analysis. I review the data, check for anomalies, and sign off on results. I ensure compliance. FDA regulations, EMA guidelines, GMP standards — I keep track of all of them. When inspectors come, I make sure everything is in order. When new regulations come out, I update our protocols accordingly. I manage and train my team. I have a group of QC analysts working under me. I make sure they're properly trained, following procedures, and staying updated on best practices. If someone's stuck, I guide them through it. I investigate quality issues. When something goes wrong — an out-of-spec result, a deviation, a complaint — I'm the one who gets to the bottom of it. I figure out what happened, why it happened, and how to prevent it from happening again. I collaborate with other departments. Production, QA, regulatory — we all work together. If there's a quality concern, I coordinate with them to resolve it. I maintain documentation. Audit trails, test reports, investigation records — I make sure everything is documented properly. Because if it's not documented, it didn't happen. I keep up with regulatory changes. The industry doesn't stand still. New guidelines, new requirements — I stay on top of them and make sure our lab is always compliant. Bottom line? I make sure that when a patient takes our product, it's exactly what they need

Stability IN charge

Sep 2018 - Sep 2020 • 2 yrs

When I worked as Stability IN charge, my main responsibility was to figure out how long a drug would actually last before it started to lose effectiveness. Companies need this data — manufacturers, hospitals, patients — everyone relies on it. Here's what my job involved: We used to take products and put them through different environmental conditions — temperature, humidity, light — to see how they held up over time. Everything from tablets to injections. I had to make sure we collected samples at specific time intervals. Then I would analyze them for potency, appearance, and how well they dissolved. The goal was to generate reliable data to determine the drug's shelf life. For example, one of our antibiotics showed a shelf life of two years under controlled conditions. That kind of information is what regulatory bodies ask for — and it's what doctors and patients depend on when they use the medication. So basically, my job wasn't just about testing. It was about making sure the drug would work when someone actually needed it.

Senior QC Analyst

Feb 2010 - Aug 2018 • 8 yrs 6 mos

As a quality control analyst, I will carry out different tasks each day to make sure that products are fit for purpose. Some of my roles and responsibilities will include: Taking and analysing samples from all stages of manufacturing or handling to ensure they meet project standards Working at different stages in production, such as raw material extraction, in-process checks or final product testing Adhering to established procedures, including standard operating procedures (SOPs), Good Manufacturing Process (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) where applicable Applying methods specific to the industry laboratory tasks and specialized testing equipment Recording findings in technical documents and laboratory reports