CAPEX & Qualification Team Senior Supervisor

PharOS Ltd in Malta is currently seeking to recruit a CAPEX & Qualification Team Senior Supervisor within the Engineering department, to join their team on a full-time basis 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
• Review functional, design and testing documentation from suppliers/contractors to ensure compliance with cGMP and Good Documentation Practices
• Leads and performs FAT, SAT, DQ, IQ, OQ & PQ activities, provides progress monitoring and prepares 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, 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.