Leads the team of Quality supervisors/engineers/technicians to support Manufacturing, Supplier Development, New Product Development, and Quality Systems. Directs projects to ensure the manufacture of high quality product and to facilitate compliance with regulatory requirements.
Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.
Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.
Directs Quality personnel to support new product development by defining projects focused on new products/process development based on coordination with management, project leaders, & design engineers.
Provides manufacturing support by defining work assignments directed to address manufacturing process defects and implement process improvements utilizing Quality System tools. May also direct work assignments for quality control auditors.
Monitors departments activities and records to ensure compliance independent action through critical decision making.
Identifies, develops and implements processes to improve department performance.
Translates department goals into individual objectives and KRAs.
Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.
Monitors compliance with company policies and procedures (e.g. compliance with FDA, EEO regulations etc).
Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.
Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.
Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
Monitors daily work operations and provides direction and guidance to, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews
Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources
A Bachelor of Chemical/Engineering/Sciences or equivalent
Minimum of 4-6yrs experience in a pharmaceutical/Medical Device environment
People Management experience desirable
For further information please contact Michelle Kilcar at CCP Recruitment on 091 730022 or email email@example.com
Apply to this job