Quality Control Supervisor

Vor 4 Tagen

Brisbane City, Österreich ISTITUTO MARANGONI Vollzeit

Work Schedule

Other

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, each one of our extraordinary minds has a unique story to tell. Join us and contribute to our singular mission - enabling our customers to make the world healthier, cleaner and safer.

When you’re part of Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world

Position Summary:

Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by the TGA, FDA, EMA and other regulatory agencies as applicable. To achieve compliance, quality systems are defined, implemented and maintained. Our team is responsible for ensuring the completion of qualification/validation protocols, batch release and stability testing. We are a quickly expanding site with ever growing opportunities. We believe our workforce are our greatest asset, and are passionate about nurturing and developing future talent

The Quality Control (QC) Supervisor will lead multiple teams within Quality Control, with laboratory team leaders reporting directly into this position.

Responsibilities include assuring timely and scientifically sound output for the Quality Control teams according to international regulatory guidelines related to assay qualification/validation, in-process production samples, final formulated products and systems with international quality requirements, and in line with the customer specific requirements.

Key Responsibilities:

  • Responsible for overseeing the day to day management of the Quality Control Laboratories, including planning of activities and resources, execution of analysis, reporting of results, and reporting of key performance indicators. Expected to demonstrate strong managerial proficiency in a fast paced, complex and dynamic regulated environment by managing multiple team leaders.
  • Establishes the goals and objectives of the team, ensuring a high level of analytical quality
  • Supports client focused outcomes for the analysis of stability study samples, method analytical transfer, and qualification and validation studies to agreed timelines.
  • Supporting PSG Brisbane Australia’s Engineering Team on equipment maintenance and calibration. Assisting the Engineering and Validation Team with equipment/system upgrades and qualification.
  • Assisting with the revenue goals of the Company through analytical testing outcomes and the release of drug substance (DS) and drug product (DP) results.
  • Leads/manages the performance of the team through effective critical metrics tracking and goal setting.
  • Ensure the effectiveness of the Quality Control Laboratories align with EH&S guidelines and Quality Standards. Strong engagement to lead and promote PPI
  • Build and nurture a high performing team through day-to-day coaching and leadership and ensuring growth and development of the Quality Control team with a focus on building talent depth and succession planning.
  • Monitors new technologies which are relevant to the QC department that may offer more cost effective and robust solutions for the company.
  • Assist with regulatory and client audits, representing all aspects of the QC Team.
  • Deputise for the QC Operations Manager when they cannot be present as well as demonstrate leadership and accountability.
  • Ensures the scientific integrity of the QC Teams is maintained, working closely with the data integrity officer.
  • Facilitates and monitors atypical, out of specification or out of trend investigations with the team to ensure swift resolution, with facilitating an appropriate resolution.
  • Practical application of various risk assessments tools (i.e. failure mode effect analysis, fishbone diagrams, hazard and operability studies) and an ability to directly develop, participate, and advise others on the appropriate and efficient application of these processes. Adherence to Quality System related to the Quality Control Department, including Change Control, Deviations, CAPA, OOS/OOT, and Documentation Management,.
  • Perform any other legitimate duties as directed by the QC Operations Manager

Frequent Contacts:

Internal

All Internal Departments including QC, QA, and Operations

External

Customers, Regulatory Agencies, Other Thermo Fisher Scientific Business both within and external to the PSG, Equipment/Contract Laboratory/Maintenance vendors and contractors.

Minimum Requirements/Qualifications:

  • Bachelor of Science (Biotechnology, Chemistry, Microbiology or closely related degree). Post Graduate qualifications – beneficial.
  • At least 2 years of experience in a leadership role. At least 5 years’ experience in the pharmaceutical and/or pharmaceutical industry aligned to Analytical and Quality Control fields.
  • Expertise with method transfer and qualification or validation.
  • Knowledgeable in cGMP practices.
  • Strong background in analytical theory and technical competency with laboratory analysis.
  • Ability to work in a highly dynamic, frequently changing environment with a wide variety of people and perspectives, working on multiple projects simultaneously.
  • Ability to effectively communicate in multiple modalities (e.g. electronic, written, verbal, etc.)
  • Good knowledge of Microsoft applications (e.g. Excel, Word, Outlook, PowerPoint), Laboratory Information Management Systems (LIMS), Smartsheets, analytical testing software.

Skills & Attributes

  • Adaptability: Ability to adapt to daily business requirements.
  • Collaborating: You will have the ability and competency to work with all departments and colleagues of varied backgrounds.
  • Continuous Improvement: Drive PPI
  • Quality Orientation: Ability to interpret and apply cGMP principles, strong attention to detail, and accurate completion of test records. Strives for right first time in every task undertaken.

Other Job Requirements:

  • Provide industry-leading customer experience.
  • Deliver the best technical and scientific solutions to enhance product value.
  • Create a culture of engagement, accountability and a shared commitment to excellence.
  • Operate our business in a compliant, safe disciplined, responsible, and ethical fashion.
  • Abide by all EH&S policies and procedures, operate our business in a safe, focused, responsible, and ethical fashion. Work safely and only perform tasks if currently competent and/or authorised, participate in EH&S activities such as; GEMBA walks, inspections, and risk assessments.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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