a) Ensures safe work environment and practices for associates in areas of responsibility.
b) Ensures compliance with and maintains certifications for G.M.Ps/G.L.P., and other pharma production-required certifications, to include internal audit functions.
c) Schedules and directs the daily activities of the Quality Control laboratory based on company priorities and objectives to ensure incoming raw materials, retest materials, and in-process and finished products
d) Optimizes allocated department resources
e) Responsible for tracking, reporting, and assessing Quality Key Process Indicators (KPIs) for facility ant the laboratory.
f) Ensures optimal Plant QA oversight including on-the-floor batch record review
g) Ensures effective operations of the Documentation Control Center, controlling S.O.Ps system
h) Control, manage and ensure effective countermeasures of Quality Control Laboratories.
i) Negotiates and authorizes customer and internal specifications.
j) Monitor and manage all QA and QC processes and teams where necessary.
k) Assists as needed in the resolution of repeat or major quality issues within the facility.
l) Provide input and direction for course of action to be taken in regard to quality systems and coordinate the implementation with plant staff and Global Regulatory Affairs. (see full list attached)
a) 5+ years of experience in Pharma manufacturing as manager n Quality domain,
b) University Degree, preferably in Biology, Chemistry or Biochemistry
c) Expertise in QC processes and External Auditing, Overall understanding of Quality Assurance specifications and process
d) Strong understanding and appreciation for regulatory requirements and quality and compliance standards
e) Demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function
f) Fluent English, native Hungarian
g) Ability to teach and motivate groups and individuals.
h) People management