Job Group: Operations

Job Sub Group: Quality Control

Job Code: OPS.QCOP.P04

Job Track: Professional

Position Location: PSG Brisbane Australia

Number of Reports: None

Position Summary:

Manufacturing of biopharmaceutical products is required to be aligned with 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. The Customer Programs team supports the studies that are required by the customer for the regulatory acceptance of their drug substance and drug product. Responsibilities include assuring timely and scientifically sound output of data from the Stability Studies, CoA/SoT generation for batch release, shipment of test samples, communicating and accepting results from external third party test facilities for each customer's project requirements.

Key Responsibilities:

Independently liaise with Clients and Project Managers regarding the performance of stability studies in alignment with ICH guidelines, batch testing for the disposition of quality product, external shipments of quality control samples and 3rd party contract testing at qualified vendors. Respond to Client queries, expectations and challenges. Generate and supply and update relevant information and results to Project Managers and Clients.

Generate Stability Study documentation including Stability Protocols, Statements of Testing and Stability Summary Reports.

Prepare and or approve shipping documentation and sample submission forms required for testing of Client samples at external facilities. Review and approve test reports supplied from external facilities.

Generate Quality Control Batch Release documentation (CoA) and In-process documentation (SoT) for Client product to facilitate on time disposition of their product.

Demonstrate an understanding of the Quality Control practices and principles.

Knowledge of a Quality System, including generation of Change Control, Deviations, CAPA, OOS and OOT, Document Management, related to the Quality Control Department.

Practical application of various risk assessments tools (i.e. failure mode effect analysis, fishbone diagrams, hazard and operability studies).

Independently initiate activities ensuring alignment to EH&S site and Global policies.

Ensures the scientific integrity is maintained by working closely with the data integrity officer.

Work directly with the program management teams to ensure stability studies and external shipments/testing contractual stages and timelines for customer projects are met.

Work with, QA and QC teams to approve product disposition and meet site expectations in the most profitable way.

Assist Program Managers to ensure customer approval and expectations are maintained.

Identify and report non-conformances directly to Supervisor and QC Manager or delegate.

Author and review protocols and reports in line with Patheon Brisbane internal policies and regulatory guidelines.

Support and liaise with the QC laboratory workers to ensure relevant testing is performed on time.

Work in accordance with Regulatory Guidelines, to deliver quality stability studies for clients.

Prepare data to support specification discussions and present in specification council meetings.

Collaborate with an active team to support PPI activities for the business.

Ensure traceability and legibility of all QC documentation.

Ensure effective execution of documentation records for client requirements.

Support generation and approval of Work Flows and MLPs in gLIMS.

Enter and authorise results in gLIMS.

Work within EH&S guidelines, Corporate Quality Standards, Standard Operating Procedures and data integrity.

Support the company's TGA licence to manufacture and test drug substance for disposition.

Perform any other legitimate duties as requested by the Manager, QC (or delegate).

Frequent Contacts:

Internal

Quality Control Laboratories

Quality Assurance department

Program Management team

Logistics and Warehouse staff

Process Engineering and Operations staff

External

Customers

Regulatory Agencies

Vendor approved test facilities

Other Thermo Fisher Scientific Business both within and external to the PSG

Equipment/ /Maintenance vendors and contractors

Bachelor of Science (Bio-Technology, Chemistry, or closely related degree).

Minimum Requirements/Qualifications:

Qualifications & Experience

Post Graduate qualifications - beneficial

At least 2 years' experience in the pharmaceutical industry witha Quality Control fields.

Proficient in generating test method development protocols, qualification data and validation reports.

Knowledgeable in cGMP practices.

Enjoy working in a highly dynamic, frequently changing environment with a wide variety of people and perspectives.

Experience in stability studies suitable for the bio-pharmaceutical industry.

Work as a team member or independently as required.

Knowledge in the use of multiple modalities (e.g. electronic, written, verbal, etc.)

Ability to handle a diverse cliental simultaneously.

Strong team-working and collaborative skills.

Good knowledge of Microsoft applications (e.g. Excel, Word, Outlook), Smartsheets and Sample Manager (gLIMS)

Skills & Attributes

Adaptability: Ability to adapt day to day business requirements.

Collaborating: Work with all departments and colleagues of varied backgrounds.

Continuous Improvement: Challenge current practices to drive PPI to support business improvements.

Focus: Deliver on promises made to customers i.e. meet agreed due dates.

Initiating Action: Work independently, and prioritise planned work. Ability to work on multiple projects or tasks simultaneously.

Managing Relations: Demonstrates the resilience to customer demands with respect to their business requirements, contacted needs and agreed timelines.

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:

Deliver strong technical and scientific solutions to improve product quality. Build a culture developed on engagement, accountability and a shared dedication to quality. 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 proficient 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.