Change Control Lead

About PSC Biotech

Who are we

PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloudbased software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.

Take your Career to a new Level

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of likeminded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.

Overview:

• Exciting opportunity exists for a Change Control Lead to join a highly skilled Project team based on site supporting a largescale capital project.
  
• Ideally candidates should have a strong emphasis on Change Control processes a GMP/GDP background and a degree in a Science and or Engineering based discipline.
  
• The role will be responsible for the ownership and management of changes through the change control system.
  
• Predominately based onsite but there is an element of working from home
  

Requirements

Responsibilities:

• The successful applicant will be responsible for initiation ownership and management of changes through the change control system. Collaboration with change initiators subject matter experts reviewers approvers and external groups through the life cycle of relevant changes. Liaising with project teams to enable schedule adherence as it relates to turnaround of changes.
  

Principal Accountabilities:

• Ownership and management of safety quality and environmental changes as associated with large strategic projects. Changes may be related to processes e.g. equipment automation utilities and facilities or other technical functions as required.
  
• Initiation of changes where deemed appropriate.
  
• Impact assessment for relevant changes.
  
• Collaboration with Change Initiators SMEs Reviewers Approvers and other stakeholders to enable successful and efficient change progression.
  
• Identification and implementation of process optimization opportunities where they arise. (e.g. Hierarchy or dependency optimization material control strategies).
  
• Maintaining accurate task scheduling per project requirements. Minimizing the number of overdue tasks through schedule management.
  
• Engagement with the Tier process to escalate changes or tasks that are off track.
  
• Overall schedule management for change control lifecycle including metric and management reporting from multiple change control platforms.
  

Core Competencies:

Technical:

• Good Knowledge/Experience managing Change Control System and proprietary software systems.
  
• Understanding of unit operations and plant equipment.
  
• Understanding of Commissioning Qualification and Validation protocols (CQV) for process equipment qualification and clean & black utilities.
  
• Knowledge of Safety and Environmental procedures
  
• High level understanding of current regulatory environment and regulations/requirements as they relate to change control.
  
• Understanding of Quality management system policies documentation and procedures.
  
• Understanding of GMP and GDP practices.
  
• Proficiency in using digital systems for full digitalisation Change Control execution.
  
• Familiar with project life cycle delivery.
  

Business:

• Excellent communication skills both oral & written.
  
• Organisation and planning skills
  
• Meetings management skills
  
• Project management skills.
  
• Data collation skills.
  
• Decision making and problemsolving skills.
  
• Interpersonal skills.
  

Leadership:

• Customer service skills.
  
• Collaboration skills.
  

Qualifications:

• Ideally candidates should have a strong emphasis on Change Control Documentation a GMP/GDP background Quality and a degree in a Science and or Engineering based discipline.
  
• Minimum of 38 years experience.
  
• Experience of working in a project environment.
  
• Hands on attitude specifically carrying out change controls to a very high standard.
  
• Excellent oral and written communication skills in English.
  
• High level of customer orientation/understanding.
  
• Time management (self) ability to deliver to timelines.
  
• Attention to detail and knowledge of Safety GMP and GDP requirements.