Job ResponsibilitiesAssist QA Assistant Manager for the full spectrum of QA function, including supervision of subordinates in the QA department, monitoring product or process quality control to enhance continual improvement.
Ensure quality of incoming and outgoing products is maintained through the use of adopted sampling methods, testing equipment, and other quality control tools.
Train subordinates to ensure their tasks are consistently performed according to specific job functions.
Ensure proper documentation control in the QA Department to guarantee required documents are available as needed.
Implement statistical process control to monitor departmental targets or objectives as necessary.
Ensure and verify corrective actions taken by relevant parties to prevent recurrence at various stages of the production process control.
Ensure any non-conformities detected at incoming, in-process, or pre-shipment stages are segregated for unintended use and reported to immediate superiors.
Regulatory Compliance: Ensure that products meet the legal requirements of the markets.
Prepare and submit necessary documents to regulatory agencies (e.g., FDA, EMA) for product approvals, renewals, and modifications.
Liaise with Regulatory Bodies: Act as the main point of contact between the company and regulatory authorities, addressing any questions or issues that arise.
Stay updated on regulations and guidelines affecting product development and marketing.
Labeling and Advertising: Ensure that product labels and promotional materials comply with regulations.
Identify potential regulatory risks and develop strategies to mitigate them.
Monitor products once they are on the market to ensure ongoing compliance and safety.
Develop regulatory strategies that align with business goals and facilitate timely product launches.
Job SpecificationDegree and above or equivalent qualification.
Comprehensive understanding of all procedures related to Quality Assurance and documentation.
Required communication and reporting skills.#J-18808-Ljbffr