Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.
Job Title: Sr. Analyst/Analyst-Quality Control
The position entitles the incumbent to possess adequate practical and technical knowledge on the Quality control techniques and related instruments.
The following areas shall be in preview of the desired candidate but the roles and responsibilities shall not be limited to:
- To do the stability testing of laboratory Batches, Pivotal batches, Commercial batches and other stability samples.
- Preparing of the stability protocols, validation protocols and finished product specifications and SOPs.
- Analysis of stability samples, working standard qualification, maintenance of working standards and certified reference standards.
- Online monitoring of stability chambers, photo stability chambers.
- Analysis of Finished products, Raw materials and in process by using calibrated instruments and conventional methods
- Calibrating instruments like pH meter, Autotitrator, UV, IR, Analytical balance and HPLC.
- Analytical method of cleaning validation by UV-VIS SPECTROPHOTOMETER.
- Adhere; follow and implement the Standard Operating Procedures (SOPs), health and safety practices/ policies.
- Prepare the work sheets and protocol for the Analytical method of cleaning validation.
- Manage change control deviations and closure of the same.
- To co-ordinate within the groups in the laboratory and give guidance for troubleshooting
- Hands on experience in Analysis of Raw materials, In process and Finished products.
- Experience in the formulation unit is a must.
- Adequate knowledge on regulatory guidelines such as ICH, FDA, EMEA.
- Candidate should be well versed with the GLP and safety practices to be followed in the quality lab.
- Should possess excellent communication skills and be able to work cohesively as one of the team members.
- The candidate should be willing to work in shifts.