QA Operations Specialist-Shift

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:

The Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team). With guidance from the Associate Director of Quality Operations the Quality Specialist ensures quality and compliance of products manufactured by the functional area adherence to Good Manufacturing and Documentation Practices and represents quality on the shop floor.

The Quality Specialist performs review of process documentation/data for accuracy completeness and data integrity compliance. The incumbent may support the completion of batch disposition activities for release of product and may assist in conducting investigation of deviations. Additionally the Quality Specialist spends significant time on the shop floor in a team environment to provide quality coaching and guidance to enable documentation to be completed right first time and to ensure compliance with cGMPs and regulatory requirements.

Shift Pattern: This is a shift role 4 x 12hr extended days followed by 4 days off)

Requirements

Role Functions:

• Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records
  
• Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures
  
• Provides presence on the shop floor to support compliance and data integrity
  
• Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aides
  
• Actively participates in the Tier process and uses this forum to make issues visible and to partner with the functional area on resolution
  
• QA support review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
  
• Will serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment Facility and Utility PQ studies Cleaning Validation SIP process validation
  
• Participates as the quality member on cross functional projects
  
• Support sustaining activities such as Change Management Deviations CAPAs Equipment Requalification and Periodic review Site Maintenance & Calibration Program
  
• Provides support to internal audits and regulatory inspections
  
• Collaborates with crossfunctional team members in the identification and implementation of continuous improvement initiatives and action plans
  
• Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records
  
• Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures
  
• Provides presence on the shop floor to support compliance and data integrity
  
• Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aides
  
• Actively participates in the Tier process and uses this forum to make issues visible and to partner with the functional area on resolution
  
• QA support review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
  
• Will serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment Facility and Utility PQ studies Cleaning Validation SIP process validation
  
• Participates as the quality member on cross functional projects
  
• Support sustaining activities such as Change Management Deviations CAPAs Equipment Requalification and Periodic review Site Maintenance & Calibration Program
  
• Provides support to internal audits and regulatory inspections
  
• Collaborates with crossfunctional team members in the identification and implementation of continuous improvement initiatives and action plans
  

• Drive continuous improvement and utilise problem solving tools
  
• Participate in continuous improvement initiatives to enhance operational efficiency and resolve issues
  

Experience Knowledge & Skills:

Required:

• Minimum 5 years of relevant postdegree work experience in GMP Manufacturing Quality Assurance or Laboratory environment Pharmaceutical/Biological Quality Operations Technical or Regulatory function supporting manufacturing or laboratory operations.
  
• This role requires a seasoned professional with the expertise with at least 5 years working knowledge in the biotech industry with specific understanding of QA operations an advantage as well as Regulatory agency engagement.
  
• Evidence of leadership skills coupled with good oral and written communication skills
  
• Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
  
• Demonstrated interpersonal skills including flexibility collaboration and inclusion skills and ability to work in a team environment
  

Preferred:

• Quality systems pharmaceutical manufacturing or laboratory processes authoring and approving GMP documents
  
• Demonstrated analytical aptitude critical thinking skills and problemsolving skills
  
• Demonstrated ability to upskill/coach others
  
• Experience working on manufacturing shop floor
  
• Familiarity with GMP documentation review and/or shop floor auditing
  

Qualifications & Education:

• Bachelor degree in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience
  

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