Radiopharmaceuticals

Responsible for site data integrity practices and proceduresRepresents the company as a subject matter expert during regulatory and customer audits for data integrity.Assists the GM-Quality in the implementation and maintenance of quality systems, and deputises on data integrity and systems compliance matters in their absenceResponsible for implementation of Quality and Business-related automated systems, including MasterControl eQMS and databases.Ensure appropriate validation of automated systems and relevant related procedures are implementedEstablishes data integrity user requirements for all equipment. Ensure all new and existing equipment / computerised systems are assessed appropriately and validated for its intended use, including the use and review of audit trails.Performs risk assessments to determine high risk equipment and audit trails and take appropriate actions to bring into compliance.Communicates actions, compliance gaps and commitments to respective areas including senior management.Ensures all equipment and systems software brought onto the site for the generation of cGMP data meets with the standards with regards to CFR21 Part 11 compliance, including the initiation and execution management of change controls as appropriate.Provide training to site and ensure compliance with data integrity requirements for both paper and electronic records as well as conducting training for new automated quality related systemsOwn, create and update procedures as necessary to ensure site data integrity awareness, accountabilities, responsibilities and the importance of regulatory requirements and expectations are proceduralised.

Manages all aspects of the QC laboratory in accordance with cGMP requirements.Manage and coordinate in-house testing and external analysis of starting materials, in-process product samples, and finished goods, to ensure testing timelines are met.Manage and coordinate stability trial timetables, testing and review to ensure testing and reporting timelines are met.Manage and perform validation, performance qualification and calibration of relevant equipment and processess, including preparation of protocols and final reports.Prepare and review controlled documentation.Deputise for GM-Quality on QC matters in their absence.Assist GM-Quality in the implementation and maintenance of quality systems

Data Integrity Compliance Officer:Responsible for departmental data integrity practices and procedures as well establishing and chairing the Data Integrity Governance Team Meetings.Ensures all new equipment and instrumentation is assessed appropriately and validated for its intended use and existence, usage and review of audit trails and 21CFR Part 11 and Annex 11 regulations.Responsible for providing gap assessments and status updates to aid Data Integrity Governance team's actions to maintain and proactively improve data integrity.Performs high risk assessments to determine high risk equipment and audit trails and take appropriate action to bring into compliance. Assist in sourcing, assessing and recommending instrumentation /equipment for purchase.Provides periodic training to all operations to ensure awareness and compliance with data integrity for both paper and electronic records, including inspector interaction and good documentation practice. Communicates actions, compliance gaps, and commitments to respective areas including senior site management and corporate.Creates/updated procedures as necessary to ensure operations awareness and importance of regulatory requirements and expectations. Routinely evaluates regulatory inspection documents and updates site procedures accordingly. Keeps the Governance Team aware of industry trends.QC Supervisor:Ensuring continuous compliance with regulatory requirements and improving day to day laboratory activities. Responsible for increasing level the of compliance to TGA, FDA and increased Data Integrity standards. Ensuring the testing for release, stability, validation and in-process testing for pharmaceuticals and raw materials are performed to approved procedures within agreed timelines by appropriately trained staff. Responsible for developing and maintaining GLP within the laboratory.

Responsible for planning and conducting individually allocated audit (assessment) workload in accordance with NATA's accreditation requirements and procedures (which involves intrastate and interstate travel). Assist in self allocation of additional assessment workload, covering existing accredited facilities (including variations to accreditations) and new applications for accreditations.Use quality assurance measures (e.g. report review process, lead assessor monitoring) to improve work practices. Ensuring Charter of Service timeframes are met. Communication of published changes to process(es) to ensure understanding.Participate in relevant meetings, including field and/or program based meetings, as necessary.Respond to client enquiries. Investigate client complaints and act upon client feedback. Act in the client management role for allocated applicant and accredited facilities. Maintain relationship with clients, ensuring that their accreditation and/or industry needs are identified and these passed onto relevant management.Understand and demonstrate an ability to apply and work within a budget. Provide reconciled records of expenditure (credit card and personal expenses) in accordance with NATA policies.Ensure monthly billing to clients is undertaken in accordance with NATA policies.

Responsible for increasing level of compliance to TGA and IPVMA standards. For the co-ordination of testing for release, stability, validation (including cleaning validation) and in-process testing for pharmaceuticals, vaccines and antigens, as well as raw materials. Responsible for developing and maintaining GLP within the laboratory. Ensuring continuous compliance with regulatory requirements and improving day to day laboratory activities. Enhancing methods to compendial requirements as well as developing procedures for the operation and maintenance of laboratory equipment to assure it is operating in compliance with cGMP. Involved in validation and transfer of methods and laboratory equipment validation including training of personnel as part of the validation effort. Various project work, including lean sigma project team.

Ensuring QC analytical equipment is maintained, performance checked, calibrated and qualified in order to be ‘fit for purpose’ for use in analytical testing of samples manufactured in the early phase and commercial assets. Providing support to the QC analytical teams on equipment breakdowns, troubleshooting and training and the use of qualified analytical equipment.

Providing analytical support to the manufacturing assets, Raw Materials testing according to current pharmacopoeias, method qualification and validation activities. Planning/task management on a day to day basis, involving all aspects of Quality Assurance. Working with the Equipment Team to maintain Raw Materials equipment.

Performing chemical, physical and separation analytical techniques including HPLC and Karl Fischer, on Topical and Parenteral dosage forms for product release using approved methods within agreed timescales.

Performing stability testing on oral dosage forms using pre-determined quality standards to meet customer requirements whilst maintaining the highest level of compliance and current Good Manufacturing Practices.

Coordinating the tasks of others and to provide hands on practical activity to transfer technology into PMQC, qualify components from alternate suppliers, manage technical information and deliver validated analytical equipment. Responsible for ensuring that all components received on site are compliant with company, pharmacopoeia and regulatory standards before release to Production. Took voluntary redundancy from this role

Undertaking the testing of topical dosage forms for stability and project work using analytical/chemical techniques including HPLC and CE, within agreed timescales.Including Feb 2006 – Oct 2006 Acting Analytical and Stability Laboratory SupervisorSterile and Topical dosage forms;Coordinating the tasks of others, review and release finished products for Parenteral dosage forms. Review and trending of stability data. Providing support in day to day activities.Undertaking the testing of Parenteral dosage forms for release, stability, intermediates, finished products and projects using analytical/chemical techniques including HPLC, GC, FTIR and UV, within agreed timescales.