Quality Assurance 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.

Requirements

Responsibilities:

• Provide direct Quality support to production and support
  areas.
  
• Provides presence on the shop floor to support compliance
  and data integrity.
  
• Review and approve GMP documentation/data for accuracy
  and completeness.
  
• Review and approve executed production documentation such
  as electronic batch records and logbooks to ensure accuracy and compliance with
  cGMPs and company procedures and ensures completion of proper remediation of
  errors.
  
• QA support, review and approval of Commissioning and
  Qualification lifecycle documents for capital projects and new equipment.
  
• QA support, review, and approval for Performance
  qualification (PQ) & Process Validation activities across site.
  
• Support sustaining and QC activities such as change
  management, deviations, CAPAs, equipment requalification, periodic review, site
  maintenance and Calibration Programs.
  
• Provides support to internal audits and regulatory
  inspections.
  
• Collaborates with cross-functional team members in the
  identification and implementation of continuous improvement initiatives and
  action plans.
  
  

Technical:

• Understanding of cGMPs and of regulatory requirements as
  they apply to the pharmaceutical field or a related area.
  

Qualifications:

General Competencies:

• Leadership skills coupled with good oral and written
  communication skills.
  
• Demonstrated interpersonal skills including flexibility,
  collaboration and inclusion skills and ability to work/ upskill/coach a team
  environment.
  
• Demonstrated analytical aptitude, critical thinking
  skills and problem-solving skills.
  

Minimum Education/Experience:

• Bachelor’s degree, in a scientific or engineering field.
  
• 3 years of relevant post-degree experience in a GMP
  environment: manufacturing,laboratory, quality, operations, technical, or
  regulatory function.