Job Title: Quality Control Lead
The Company:
Our Client is a biopharmaceutical company and is recognized for its pioneering work in developing innovative immunotherapies, particularly in the field of cancer treatment, by harnessing the power of the immune system. Their dedicated team of experts and scientists is committed to pushing the boundaries of medical advancements and improving patient outcomes through transformative treatments.
Role Description:
In the role of Team Lead for QC Analytical, your responsibilities encompass overseeing, managing, and orchestrating a team of QC analysts. This team’s core objective revolves around conducting tests on in-process samples for both commercial and clinical purposes, evaluating final drug products, assessing incoming materials, and conducting stability sample analyses.
Responsibilities:

•  Leading investigations and facilitating continuous improvement initiatives.
• Drafting, reviewing, and/or executing deviations, change controls, and CAPAs.
• Monitoring the adherence of existing GMP systems to documented policies and safety regulations.
• Assuming responsibility for the Quality Control (QC) data release of the final product.
• Serving as a consultant and technical expert for your team.
• Coordinating and executing training for new personnel while maintaining training records for the QC analytical group.
• Collaborating with the team to diagnose challenges and offer effective solutions.
• Developing, reviewing, and/or implementing revisions to controlled documents (SOPs, Specifications, Methods, etc.).
• Acting as a subject matter expert during audits and Regulatory Inspections.
• Fulfilling additional responsibilities as directed by QC management.

Requirements:

• Full working knowledge of GMPs, pharmacopoeia and regulatory requirements.
• Proficient in application of QC principles, concepts, industry best practices and standards
• Proficiency in quality control systems, methods, and procedures for routine and non-routine analysis of raw materials.
• Experience in writing and implementing deviations, change controls and CAPAs
• Experience in writing or updating SOPs and analytical methods
• Willingness and ability to work in shifts (day shifts, including Saturdays and Sundays)

Other Information:
Are you ready to take a new step in your career? If you are interested or know someone who is interested, please contact Syed Zakir, and upload your resume using the apply button.