Quality Assurance Manager
1 week ago
We are seeking a Quality Control Manager to join our reputable pharmaceutical company, known for its innovative advancements in drug development.
About the RoleThe Quality Control Manager will be responsible for overseeing daily QC Chemistry laboratory operations, ensuring excellence in all analytical laboratory techniques and investigations. Key responsibilities include organizing, evaluating, and communicating priorities related to investigations, change controls, releases, ordering, instrumentation, and CAPAs generated in the QCC laboratories.
The successful candidate will have expertise in analytical lab techniques and investigations, proven leadership skills, and a passion for excellence. They will collaborate with functional areas to ensure QCC instrument qualification, validation, and maintenance/engineering activities are performed per company procedures.
Responsibilities- Organizing, overseeing, and evaluating daily QC Chemistry laboratory operations to maintain Quality Standards and project timelines.
- Communicating priorities related to investigations, change controls, releases, ordering, instrumentation, and CAPAs generated in the QCC laboratories.
- Conducting, authoring, or approving deviations related to QCC Analytical procedures to investigate root cause, determine impact, and corrective and preventive actions.
- Collaborating with functional areas to ensure QCC instrument qualification, validation, and maintenance/engineering activities are performed per company procedures.
- Authoring, revising, and approving controlled documents such as SOPs, specifications, test methods, protocols, reports, validation documents, and work instructions.
- Leading and participating in third-party and regulatory audits.
- Maintaining a safe working environment in the laboratory, including reporting and trending of SOSPES observations.
- Bachelor's degree in a scientific discipline, preferably in chemistry or biochemistry.
- Ten or more years in a pharmaceutical setting, or a master's degree in a scientific discipline with seven or more years in a pharmaceutical setting.
- Four or more years of experience in a supervisory position required.
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