Robert Mclean Email and Phone Number
Highly credentialled Quality Manager, Senior GMP Auditor and Trainer, of widely recognised expertise in leading audits, investigations and quality issue decision making, with impressive results in both the international pharmaceutical and engineering industries. Proven track record in the conduct and delivery of audit outcomes, training and measured quality decisions leading to the development, manufacture and distribution of life changing pharmaceutical products.Deep knowledge of global and industry specific Quality Systems, including those for Pharmaceutical GMPs, Excipients, Medical Devices and ISO 9001:2015, both requirements of and auditing against.Detailed knowledge of and experience in sterile, solid dose and raw materials manufacture, with assessment of laboratory practices, data integrity and validation.Proven leadership skills in running a department, teaching and training and executing projects.Exceptionally literate, with well above average writing and reviewing skills. Double KPI was achieved in a number of years in peer review and approving the reports of colleagues. Selected Achievements: -Major role in 2023 at bringing the new CSL Pty Ltd 655 Elizabeth St facility online. -Built relationships with Viatris joint venture partners in Malaysia and South Korea, enabling the delivery of important, sterile Biosimilar products into the market.-Preparation of local and international Viatris manufacturing sites to Australian TGA and international GMP standards for regulatory GMP compliance audits. The resultant system improvements led to improved audit outcomes and quality products.-Frequent remediation of findings from regulator audits, including the FDA. This enabled Viatris to continue sales and product launches in the associated markets.-Achieved double KPI in successive years in peer review and approving colleague reports, leading to much faster turnaround in the supplier qualification program and timely product launches. Skills:-Auditing third party suppliers and contractors to local and international Pharmaceutical GMP standards, -Familiar with all types of pharmaceutical manufacturers, such as API, Excipient, Biosimilars, Finished Drug Form, Sterile and non-Sterile. -An exceptional knowledge of Quality Systems, including for Pharmaceutical GMP and ISO 9001 standards.-Gifted trainer.-Mandarin Chinese language. -Public relations in conducting plant tours for a wide range of corporate guests, demonstrating the company ethos, product quality and an ability to "think on my feet" when answering questions. -Financially savvy.
Dominion Salt Ltd
View- Website:
- dominionsalt.co.nz
- Employees:
- 41
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Laboratory ManagerDominion Salt Ltd Aug 2024 - PresentTauranga, Bay Of Plenty, New ZealandManager of the Dominion Salt QC Laboratory and API Release Specialist. -Providing excellent customer service to the market thorough timely release of API product.-Managing a diverse laboratory team and delivering on servicing the API plant.-A complete and successful overhaul of API endotoxin contamination risk. -Writing a variety of GMP and ISO procedures and providing GMP Assessment advice to Senior Management.-Leading the CAPA response on Regulator and Customer audit observations.-Development of the solution to address the Dominion Salt Technically Unavoidable Particle (TUPP) issue.-Certified GMP trainer.
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Quality, Training And Compliance ManagerSpotless Group Oct 2022 - Aug 2024Melbourne, Victoria, AustraliaQuality, GMP and Training Manager for Downer GMP organisations.-Successful preparation of the new CSL 655 Elizabeth St pilot manufacturing site to Australian TGA and international GMP standards (US FDA, EU and PICs), leading to better research outcomes, better quality systems and better products. -Managing the Downer training program for the 655 Elizabeth St team, preparing more than 50 staff for GMP roles they had no prior experience in. -Writing Downer internal training courses, courses on safety, quality and general company policy.-On-the-job quality systems training of Downer Managment. -Writing a wide variety of GMP and ISO procedures and providing GMP Assessment advice to Senior Management.-Supplier Qualification of suppliers for GMP purposes, assisting them to achieve better systems and better raw services for Downer to purchase.-Providing excellent customer service to CSL in their new, 655 Elizabeth St facility.-Working in a diverse team and delivering training courses on diversity.-Certified CSL trainer. Am GMP current from CSL's training program. -
Global Operations Senior AuditorViatris Jun 2011 - Jun 2022-Preparation of local and international Viatris manufacturing sites to Australian TGA and international GMP standards, for regulator GMP compliance audits (US FDA, EU and PICs), leading to better audit outcomes, better quality systems and better products. -Remediation of warning letters and other audit observations on other Viatris sites, leading to better in house systems and also better products. -Writing annual GMP training courses, courses on Excipient auditing and how to write an audit report, leading to a more effective in house quality system and a better supplier qualification program.-On-the-job annual training of at least two Junior Auditors and other staff. -Review and approval of the work of other auditors, in particular audit reports, sometimes achieving double review KPI over twelve months. Audit reports in particular were distributed much sooner, facilitating product launches as a result. -Auditing Viatris third party suppliers and contractors to local and international Pharmaceutical GMP, Medical Device and/or ISO standards. Audits of raw material, product and packaging suppliers, including sterile goods manufacture and handling were routine.-Writing audit reports and providing GMP Assessment advice to Senior Management.-Processing CAPA (Corrective Action, Preventative Action) responses from suppliers, assisting them to achieve better systems and better raw material products for Viatris to purchase.-Employee representative on the company superannuation fund, giving employees choice in investments.-Working in a diverse and internationally based team, learning about diversity and achieving better cross cultural understanding. -Managing international travel and expenses, developing a reputation for finding the best, most effective and cheapest way to travel. Was timely and effective in reporting on expenditure. -
Global Operations AuditorMylan Dec 2008 - Jun 2011Brisbane, Queensland, Australia-Establishing the Mylan external audit (supplier qualification) program in the Asia Pacific (APAC) Region, enabling Mylan to source materials in the far east in compliance with GMP standards. -Lived and worked in Japan for five months whilst establishing the external audit program, training Japanese colleagues in how to qualify a Viatris supplier, particularly for export from Japan. -Auditing Viatris third party suppliers and contractors to local and international Pharmaceutical GMP, Medical Device and/or ISO standards. Experience with audits of raw material, product and packaging suppliers, including sterile goods manufacture and handling.-Working with a diverse and internationally based team and learning how to do business in different cultures.-Writing audit reports and providing GMP Assessment advice to Senior Management.-Processing CAPA (Corrective Action, Preventative Action) responses from suppliers, assisting suppliers to improve their Quality systems.-Employee representative on the company superannuation fund, managing $76 million on behalf of members, providing them with investment choices.-Managing international travel and expenses. -
Release For Sale AssociateMylan Apr 2002 - Dec 2008Brisbane, Queensland, Australia-Helping establish the Release Department and its procedures, significantly reducing backorders in the process.-Performing Release for Supply to market on a wide range of finished drug products, including solid dose, liquids and sterile goods.-Working in a team supporting quality investigations and documentation in the manufacturing departments. Decision making on Quality Issues and initiating better investigations into Quality Issues.-Review and approval of SOPs as the delegate of the QA Manager, eliminating a significant backlog and enabling the contemporary, correct procedures to be used.-Employee representative on the company superannuation fund.-Conducting public relations for the company in the form of plant tours, demonstrating the ethos of the organization, quality of product and fielding a wide variety of questions in real time.
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Gmp Compliance SupervisorAlphapharm Jun 1993 - Apr 2002Brisbane, Queensland, Australia-Managing the Compliance Department and three staff, greatly improving GMP documentation in manufacturing.-Managing the deviation and fault analysis system, leading to proper recording of Quality Issues for the first time.-Decision making on Quality issues, such as investigations, deviations and Out Of Specifications (OOS).-Audit of Batch manufacturing documents to GMP standards, helping eliminate backorders.-Writing GMP training courses, which improved manufacturing practices and therefore products. -Employee representative on the company superannuation fund.-Managing waste disposal for the organisation. -
Restricted Substances ManagerFaulding Pharmaceuticals Nov 1992 - Jun 1993Melbourne, Victoria, Australia-Dispensing narcotic (S8) drugs to production and customers. Reducing backorders by 90% and giving customers friendly, helpful service.-Managing the dispensary and two staff, including qualifying a new dispensary in that time.-Maintaining thorough security and record keeping procedures.-Removing narcotic rejects and arranging for their destruction, resolving a storage issue. -
Dispensary SupervisorFaulding Pharmaceuticals Jan 1989 - Nov 1992Melbourne, Victoria, Australia-Dispensing raw materials to production.-Liaising with various Hospira and Government departments.-Inventory management.-Sampling raw materials in aseptic conditions.-Managing staff.
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Senior Quality Assurance AnalystFaulding Pharmaceuticals Feb 1988 - Jan 1989Melbourne, Victoria, Australia-Investigative work finding solutions with troublesome products and processes.-Report writing on Laboratory and production matters.-Testing raw materials and finished products.-Advising the departmental manager on technical matters.-Training new staff, both graduate and year twelve level.-Preparing for foreign health department inspections (including the US FDA).
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Quality Assurance ChemistFaulding Pharmaceuticals Nov 1986 - Feb 1988Melbourne, Victoria, Australia-Testing over 300 raw materials and products.-Calibration of instruments.-Laboratory investigations and report writing.
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Research And Development ChemistFaulding Pharmaceuticals Jul 1986 - Nov 1986Melbourne, Victoria, Australia-Undertaking shelf life (stability) studies of injectable drugs.-Obtaining scientific data necessary to register new products with health departments, including the US FDA
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Technical Services OfficerImperial Chemical Industries (Ici) Nov 1985 - Jul 1986Melbourne, Victoria, Australia-Development of Polyurethane foams for refrigeration, footwear, insulation, domestic and automotive use.-Assessment of product performance in materials science.-Visiting customers and resolving their technical problems.
Robert Mclean Education Details
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First Class Honors -
National On Site Training (Nost)Pass -
Second Class Honors
Frequently Asked Questions about Robert Mclean
What company does Robert Mclean work for?
Robert Mclean works for Dominion Salt Ltd
What is Robert Mclean's role at the current company?
Robert Mclean's current role is Experienced Quality, Training and Auditing professional.
What schools did Robert Mclean attend?
Robert Mclean attended University Of Melbourne, National On Site Training (Nost), The University Of Queensland.
Who are Robert Mclean's colleagues?
Robert Mclean's colleagues are Daniela Budure Olsen, Micheal Tautari, Kimberley Tulloch, Gary Byrom, Max Veldkamp, Maria Jose Cornejo, Eric Lim.
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