Responsibilities:
– Lead the quality control functions within the organization
– Oversee the operations of the Quality Control lab for raw materials, packing materials, finished products, and stability analysis
– Ensure the development, writing, revising, and approving of departmental SOPs, ensuring regulatory compliance and operational suitability
– Thorough review of analytical data and ensuring timely reviews to meet business milestones
– Escalate any issues appropriately through the relevant tier processes
– Continuously improve local work procedures and capture efficiency gains
– Conduct risk assessments for analytical activities and implement improvements
– Approve instrument qualification documents in line with regulatory requirements
– Review and approve protocols and reports for method validation, method transfer, process validation, cleaning analytical method validation, and stability studies
– Timely reporting of any risks to compliance or product quality to quality leadership
– Approve all change controls, deviations, and CAPA arising from the quality control laboratory in coordination with cross-functional teams
– Ensure completion of method transfer and method validation/verification before routine testing
– Ensure preparation and availability of calibration schedules for QC equipment and ensure compliance
– Manage all validation activities, including strategy and approval of protocols and reports
– Ensure appropriate investigation of discrepancies, errors, OOS, OOT, and actions
– Ensure the Quality Control department meets or improves on budget, cost, volume, and efficiency targets (KPIs)
– Identify resource and skill gaps, recruit staff as required, and effectively outsource projects as needed
– Lead a team of professionals and provide training on quality policies, procedures, regulations, and guidelines
– Implement and ensure current GMP, safety, and GLP norms in laboratory testing areas
– Stay aware of current guidelines, policies, procedures, and techniques of quality control
– Maintain laboratory compliance and safety
– Allocate work to team members in QC and ensure optimum resource utilization
– Review and approve specifications, standard operating procedures, trends, technical reports, out of specifications, and deviation reports as required
– Review and approve packing materials, raw materials, intermediate products, finished products, stability samples, and other miscellaneous samples
– Review and approve documents within QC
– Ensure appropriate training and enhancement of analytical skills and competency for subordinates
– Provide usage decisions for tested samples of raw materials, packing materials, and finished products
– Perform due diligence and evaluation of new product introductions
– Utilize knowledge of process excellence tools (Lean, Six Sigma) to improve operational performance
– Perform any other work assigned by quality leadership
Qualifications:
– Bachelor’s or Master’s degree in pharmacy or master’s degree in science with an analytical chemistry background
– Experience in pharmaceutical products and processes
– Strong leadership and team management skills and experience
– Credible and confident communicator, both written and verbal, at all levels
– Strategic thinker with the ability to influence
– High level of ethics and integrity
– Strong analytical and problem-solving ability
– Working knowledge of Microsoft Excel, Word, PowerPoint, etc.
– Relevant experience in the regulated pharmaceutical industry
– Experience with health authority inspections and third-party audits
– Technical writing skills
Benefits:
– Opportunity to join a dynamic organization where decisions are made quickly
– Chance to actively participate in shaping the future of the organization
– Work in a rapidly growing environment
– Potential to make a real difference with your contributions
– Equal Opportunity Employer