CPV Project Manager

Continued Process Verification (CPV) Project Manager

Τhe position holder will be required to:

• Manage the Continued Process Verification program across the Drug Products portfolio of FAMAR.
• Coordinate and lead a central team of CPV Assessors intended to deliver the respective CPV documentation.
• Implement the Continued Process Verification program at group level.
• Deliver the respective CPV documentation (Protocols, Risk Assessments, Reports).

The Continued Process Verification (CPV) Project Manager will act as the main point of contact of CPV related activities with customers and manufacturing sites, reporting to Group Quality Product and Process Validation Manager.

The position can be based in Athens (GR), Milan (IT) or Madrid (ES).

 DUTIES AND RESPONSIBILITIES:

• Participate in the compilation process of CPV documentation (Protocols, Risk Assessments, Reports).
• Conduct a CPV Risk Assessment according to the company SOPs while following the principles of Quality Risk Management (FMECA).
• Perform data mining and review of the Quality Data Summary of each product.
• Identify the respective CQAs, CMAs, CPPs.
• Conduct a Process Capability Analysis.
• Construct Control Charts and establish statistically derived Control Limits.
• Analyze data from production and laboratories and support other departments to identify root cause, define recurrent problems and delineate resolution of complex quality issues.
• Evaluate trends and recommend improvements in production and site operation process.
• Drive compliance with Current Good Manufacturing Practices (cGMP) and other regulatory requirements in a regulated manufacturing environment.
• Support deviation system from Quality perspective to assure adequacy of Root Cause Analysis, Correctives/Preventives Actions and Product Impact.

PROFILE / SKILLS:

Languages:

• Must be fluent in English (advanced oral and written skills). Knowledge of Greek, Italian or Spanish language will be considered an advantage.

Academic Background

• Bachelor’s and/or Master’s Degree in the area of Chemical / Industrial / Pharmaceutical Engineering

Special Knowledge

• Computer proficiency: Word, Excel, Power Point, Minitab.
• Good knowledge of Intranet applications such as SharePoint is a plus.
• Knowledge of statistical data analysis, Six Sigma techniques, Data mining, Lean techniques, process improvement, project management, quality assurance/systems, Quality Risk Management, change management, regulatory compliance.

Qualifications

• At least 3-5 years of experience in a position relevant to Pharmaceutical Technology or Quality Assurance Operations.
• Strong written and verbal communication skills (ability to present complex information to others clearly and logically).
• Must have strong team working skills and be able to collaborate effectively and build constructive relationships with clients and colleagues across the FAMAR sites.
• Manage time effectively in order to meet targets and deadlines.
• Optimal reporting and alerting capabilities.
• Ability to constructively handle and resolve conflicts and tensions within peers and/or team members.
• Ability to envision and drive continuous improvement initiatives.
• Hands-on experience in writing SOPs, investigations and other types of protocols.
• Proficient in Quality Risk Management methodologies and investigative techniques to identify root causes, implement corrective/preventive actions, and assess their effectiveness.
• Strong attention to detail.
• Ability to work under pressure.