CAPEX & Qualification Team Supervisor - Malta Based
4 weeks ago
Birżebbuġa, Malta
PharOS Ltd
Full-time
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Founded in Athens in 2002, PharOS is a privately-owned pharmaceutical Company, developing and supplying generics value added products with a global portfolio. Our expertise covers all aspects of product development from API sourcing up to market release. We provide a broad portfolio of products and intellectual property to leading pharmaceutical companies.
At PharOS, we have a high skilled workforce of more than 430 professionals. Biologists, Chemists, Pharmacists and Experts all focused on developing and placing in the market top quality generic and other value-added pharmaceuticals that improve the lives of patients to more than 98 countries. Our people are our core competitive advantage that helps us being one of the fastest growing pharmaceutical development companies in Europe. For PharOS our customers, are our partners Our aim is to extend the lifecycle of the product, as our people are able to provide an exceptional level of customer service and support, based on their expertise and professionalism.
PharOS is seeking for a CAPEX & Qualification Team Supervisor within the Engineering department as follows:
Key responsibilities
Manages CAPEX and non-CAPEX engineering projects and qualification activities, making detailed plans to accomplish goals within the established time frames. Develops project objectives by reviewing project proposals and plans and determines project specifications by studying equipment user requirements and performance standards. Determines project responsibilities by identifying project phases and elements, prepares cost estimates, calculates time frames and prepares project schedules and timelines. Assigns responsibilities and mentors the projects and qualification team. Regularly monitors and reports on project schedules, progress and spending, ensuring that activities are closed within the established time frames and budget. Coordinates with various teams and stakeholders to ensure that projects’ goals are met and up to the required quality standards. Leads and develops the projects and qualification team and manages/supervises external Contractors/Consultants working on Engineering Projects. Develops and updates qualification master plans and creates, populates and maintains databases for tracking qualification activities, test results and qualified systems. Prepares specific user requirement specifications (URS) for new equipment, utilities and software. Prepares, maintains and reviews validation or qualification protocols for new or modified manufacturing processes, systems, equipment, utilities and software, in accordance with internal and external quality, regulatory and safety requirements. Reviews functional, design and testing documentation from suppliers/contractors to ensure compliance to cGMP and Good Documentation Practices. Leads and performs FAT, SAT, DQ, IQ, OQ & PQ activities, provide progress monitoring and prepare related reports. Requirements Degree or Advanced diploma in an Engineering discipline. Three years’ experience in a similar position preferably in the pharmaceutical industry and a proven track record of continuous improvement achievement. Proven project management experience in a manufacturing environment. Experience in multiple GMP qualification disciplines (process equipment, utility, automation, computer systems, etc.) with advanced technical knowledge. PharOS Ltd Offers Competitive remuneration package (including bonus based on performance) Private medical scheme Continuous training Friendly and challenging working environment Relocation package PharOS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, or any other basis protected by applicable law, and will not be discriminated against on the basis of disability. Please note that your resume and any personal information you have provided will be stored in our system for a period of one year, after which it will be deleted.
Key responsibilities
Manages CAPEX and non-CAPEX engineering projects and qualification activities, making detailed plans to accomplish goals within the established time frames. Develops project objectives by reviewing project proposals and plans and determines project specifications by studying equipment user requirements and performance standards. Determines project responsibilities by identifying project phases and elements, prepares cost estimates, calculates time frames and prepares project schedules and timelines. Assigns responsibilities and mentors the projects and qualification team. Regularly monitors and reports on project schedules, progress and spending, ensuring that activities are closed within the established time frames and budget. Coordinates with various teams and stakeholders to ensure that projects’ goals are met and up to the required quality standards. Leads and develops the projects and qualification team and manages/supervises external Contractors/Consultants working on Engineering Projects. Develops and updates qualification master plans and creates, populates and maintains databases for tracking qualification activities, test results and qualified systems. Prepares specific user requirement specifications (URS) for new equipment, utilities and software. Prepares, maintains and reviews validation or qualification protocols for new or modified manufacturing processes, systems, equipment, utilities and software, in accordance with internal and external quality, regulatory and safety requirements. Reviews functional, design and testing documentation from suppliers/contractors to ensure compliance to cGMP and Good Documentation Practices. Leads and performs FAT, SAT, DQ, IQ, OQ & PQ activities, provide progress monitoring and prepare related reports. Requirements Degree or Advanced diploma in an Engineering discipline. Three years’ experience in a similar position preferably in the pharmaceutical industry and a proven track record of continuous improvement achievement. Proven project management experience in a manufacturing environment. Experience in multiple GMP qualification disciplines (process equipment, utility, automation, computer systems, etc.) with advanced technical knowledge. PharOS Ltd Offers Competitive remuneration package (including bonus based on performance) Private medical scheme Continuous training Friendly and challenging working environment Relocation package PharOS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, or any other basis protected by applicable law, and will not be discriminated against on the basis of disability. Please note that your resume and any personal information you have provided will be stored in our system for a period of one year, after which it will be deleted.
