QA Operations Specialist-Shift

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Dublin
• State/Province Dublin
• Country Ireland

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

'Take your Careerto a new Level'

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee ValueProposition

Employees are the "heartbeat" of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient's expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Overview:

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

The Quality Specialist performs review of processdocumentation/data for accuracy, completeness, and data integrity compliance.The incumbent may support the completion of batch disposition activities forrelease of product and may assist in conducting investigation of deviations.Additionally, the Quality Specialist spends significant time on the shop floorin a team environment to provide quality coaching and guidance, to enabledocumentation to be completed right first time, and to ensure compliance withcGMPs and regulatory requirements.

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

Role Functions:

• Responsible for review/approval of new and updated MasterBatch Records / Electronic Batch Records
  
• Review and approve production documentation such asexecuted electronic batch records and logbooks to ensure accuracy and compliancewith cGMPs and company procedures
  
• Provides presence on the shop floor to support complianceand data integrity
  
• Review and approve new and updated SOPs/ WorkInstructions and Controlled Job Aides
  
• Actively participates in the Tier process and uses thisforum to make issues visible and to partner with the functional area onresolution
  
• QA support, review and approval of Commissioning andQualification lifecycle documents for capital projects and new equipment.
  
• Will serve as the Quality SME for Performancequalification (PQ) activities across the site including but not limited to:Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, processvalidation
  
• Participates as the quality member on cross functionalprojects
  
• Support sustaining activities such as Change Management,Deviations, CAPAs, Equipment Requalification and Periodic review, SiteMaintenance & Calibration Program
  
• Provides support to internal audits and regulatoryinspections
  
• Collaborates with cross-functional team members in theidentification and implementation of continuous improvement initiatives andaction plans
  
• Drive continuous improvement and utilise problem solvingtools and participate in continuous improvement initiatives to enhanceoperational efficiency and resolve issues
  

Experience,Knowledge & Skills:

Required:

• Minimum 5 years of relevant post-degree work experiencein GMP Manufacturing, Quality Assurance or Laboratory environment,Pharmaceutical/Biological Quality, Operations, Technical, or Regulatoryfunction supporting manufacturing or laboratory operations.
  
• This role requires a seasoned professional with theexpertise with at least 5 years working knowledge in the biotech industry withspecific understanding of QA operations an advantage as well as Regulatoryagency engagement.
  
• Evidence of leadership skills coupled with good oral andwritten communication skills
  
• Understanding of cGMPs and of regulatory requirements asthey 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 orlaboratory processes, authoring and approving GMP documents
  
• Demonstrated analytical aptitude, critical thinkingskills and problem-solving skills
  
• Demonstrated ability to upskill/coach others
  
• Experience working on manufacturing shop floor
  
• Familiarity with GMP documentation review and/or shopfloor auditing
  

Qualifications& Education:

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