Senior QA CQV Specialist

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 cloud -based 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 like -minded 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
diverse -cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide
unparalleled empowering career development though Learning & Development
in -house 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:

The Quality team have a great opportunity for a Quality
Assurance Senior Specialist at our facility.

QA CSQ/CQV specialist contractor/Consultant, he will be
reporting to the QA CSQ/CQV Lead. This role is responsible for oversight of all
validation activities ensuring compliance with current regulatory requirements,
cGMP and company SOPs. It includes validation/qualification activities for
facilities, utilities, equipment, computerized systems, cleaning, processes,
storage areas, controlled temperature units (CTUs) and shipping. An important
aspect of this role is provision of QA oversight to the Commissioning,
Qualification and Validation (CQV) activities associated with the Facility
start -up project and supporting the transition from project phase through to
sustaining phase with respect to validation activities

Requirements

Requirements:

Education background/ Experience:

• B.Sc or B.Eng in a Scientific or Engineering related
  discipline (e.g. biochemistry, chemistry, engineering).
  
• Experience in a Quality Engineering/Quality
  Assurance/Quality Validations role for Biologics or related pharmaceutical/
  medical device manufacturing in a FDA/ EU regulated environment.
  
• Thorough understanding of the validation requirements
  associated with a cGMP manufacturing facility
  
• Strong technical aptitude is required.
  

Special knowledge:

• Deep knowledge of GxP regulations applicable to biologics
  manufacturing (e.g. EU -GMP, FDA, ISO) and the industry standards applicable to
  validation, including but not limited to; GAMP, ISPE, ISO, ASME and BPE.
  
• Knowledge of trouble shooting and problem -solving skills.
  Knowledge of formal root cause analysis methods and tools such as Ishikawa
  diagrams, FMEA etc.
  

Skills :

• Independent and self -motivated.
  
• Able to multi -task in fast -paced, dynamic working
  environment.
  
• Strong planning, organisational, and time management
  skills.
  
• Critical thinking skills.
  
• Able to operate across functional boundaries, both
  internal and external.
  
• Other requirements (e.g.: working time)
  
• On -site role
  

Responsibility:

• Ensure the quality oversight of the
  qualification/validation activities of all facilities, utilities, equipment,
  computerized systems, cleaning processes, manufacturing processes, storage
  areas, controlled temperature units (CTUs) and shipping processes.
  
• Ensure that all validation documentation and associated
  data, including but not limited to; plans, URSs, quality risk assessments,
  protocols, and reports, are reviewed and approved by QA for conformance to
  SOPs, specifications and other applicable acceptance criteria.
  
• Ensure that all events/deviations, investigations, and
  change evaluations that occur during qualification/validation activities have
  appropriate QA oversight, QA review and approval and adhere to SOPs and cGMP
  requirements.
  
• Review SOPs relating to qualification/validation
  activities.
  
• Provision of support in Regulatory inspections and Client
  audits.
  
• Provision of QA Validations expertise to maintain
  validation status of the facility.
  
• Maintain an understanding of cGMP regulations and
  guidance in relation to all aspects of validation and/or qualification of
  facilities, utilities, equipment, computerized systems, cleaning processes,
  manufacturing processes, storage areas, controlled temperature units (CTUs) and
  shipping processes.
  
• Coordinate all QA Validations activities to ensure
  schedule adherence and on time delivery of project deliverables.
  
• Manage and develop the QA Validations team including, but
  not limited to, activities such as performance management, recruitment, and
  training.
  
• Other quality activities as needed and assigned.