QA Associate-Shift

PSC Biotech Corporation; Cork; On-site; EUR 70,000 - 110,000; Full time

Job summary

PSC Biotech Corporation is seeking an experienced QA professional to support the start-up and ongoing QA of sterile drug product filling operations in Cork, Ireland. The role reports to the QA Operations Manager and requires hands-on quality leadership across technical transfers, change controls and GMP documentation.

The ideal candidate has 5+ years in pharmaceutical/biotech QA, strong knowledge of FDA/EMEA standards, and proven ability to drive CAPAs and deviations while promoting continuous

Qualifications

• Required: Degree or 3rd level qualification (Science, Quality). QP Qualification would be an advantage.
• Required: Demonstrated experience in Sterile Drug Product Filling and start-up of same.
• Required: Relevant experience (5+ yrs) in a Quality function in pharmaceutical/biotech industry or equivalent.
• Required: Knowledge of FDA/EMEA regulations/standards and quality systems.
• Required: Proficiency in PC skills such as Excel, Word, PowerPoint.
• Required: Strong written and verbal communication skills.

Responsibilities

• Provide Quality direction and oversight of start-up, technical transfer, operation, and continuous improvement of Sterile Drug Product Filling operations.
• Provide Quality input to Change Controls, Protocols and Reports ensuring clear scope of records and timely implementation.
• Write, review and approve SOPs, Work Instructions, MTAs, Master Batch Records, Specifications and other GMP documentation.
• Participate in cross-functional project teams to address issues in real time to meet timelines.
• Lead tasks to ensure critical activities are completed on time and to requirements.
• Provide Quality input to Deviations and CAPAs for timely closure with robust documentation.
• Support pre-approval regulatory inspection readiness for approvals.
• Assist with Quality Assurance elements needed for new product launches.

Skills

Sterile Drug Filling

Quality function experience

FDA/EMEA knowledge

Root Cause Analysis

Validation knowledge/experience

Lean / Continuous Improvement

MS Office (Excel/Word/PowerPoint)

Education

Degree in Science/Quality

Job description

• Industry Pharma/Biotech/Clinical Research
• Work Experience 5+ years
• City Cork
• State/Province Cork
• Country Ireland

Job Description

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 Career to 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 Value Proposition

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:

• A high level of initiative, energy and motivation are keyrole requirements, as well as excellent organizational skills.
  
• As part of establishing sterile filling operations at thefacility, this role (which reports to the QA Operations Manager) will provideQA support for the start-up of the facility, before moving into routine QAsupport of same.
  
• The successful candidate will also have proven capabilityin promoting Quality across cross-functional teams, to deliver on-time highquality processes and products, whilst ensuring continuous process improvement.
  
• This is a shift role and a 12 Month of Contract
  

Requirements

Key Responsibilities:

• Provide Quality direction and oversight of the start-up,technical transfer, operation, and continuous improvement of Sterile DrugProduct Filling operations.
  
• Provide Quality input to Change Controls, Protocols andReports ensuring scope of records are clear and implementation activities arerobust and timely.
  
• Write, review and approve Standard Operating Procedures,Work Instructions, Quality Technical Agreements, Master Batch Records,Specifications and other GMP documentation in accordance with Policies.
  
• Participates within inter-departmental andcross-functional project teams to immediately address issues and questions inreal time to help ensure project timelines are achieved.
  
• Prioritizes tasks to ensure the critical tasks arecompleted on time and meet requirements.
  
• Provide Quality input and guidance to ensure Lot Release(Components/Raw Materials/Drug Product) of high quality products in compliancewith current Good Manufacturing Practices (GMPs).
  
• Compilation of Lot Release Packs as per requirements ofSOPs, WIs and related FRMs.
  
• Provide Quality input to Deviations ensuring scope ofrecord is clear and implementation activities are robust and timely. Review andapproval of Deviations and associated CAPAs for closure ensuring compliancewith appropriate documentation, whilst ensuring that CAPA actions address rootcause and implementation plan dates are achievable.
  
• Exercise judgment to determine appropriate action,ensuring proper escalation when issues are identified as per applicableprocedures for compliance, escalation and corrections
  
• Pro-actively identifies compliance risks and takesappropriate preventative actions.
  
• Proactively identify potential issues, lead root causeanalysis, make recommendations and aid in implementation for more complex andnon-reoccurring issues.
  
• Ensure high level of Quality / cGMP Awareness in theProject Team and Sterile Filling Team.
  
• Lead Area GMP Certification Activities.
  
• Support pre-approval Regulatory Inspection readiness toensure regulatory approvals are obtained.
  
• Support all Quality Assurance elements needed tofacilitate new product launches.
  

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLSREQUIREMENTS

Required:

• Degree or 3rd level qualification (Science, Quality). QPQualification would be an advantage.
  
• Demonstrated experience in Sterile Drug Product Fillingand start-up of same.
  
• Relevant experience (5yrs +) working in a Qualityfunction in the pharmaceutical or biotechnology industry or other combinationof experience and educational background that may otherwise satisfy the otherrequirements of the role.
  
• Demonstrates good knowledge of FDA / EMEAregulations/standards and quality systems.
  
• Demonstrated ability to work independently and fullyrealize improvement initiatives with a moderate level of guidance.
  
• Demonstrated ability to work and succeed within teams aswell as leading small project teams while maintaining and strengthening trustrelationships with people on all levels.
  
• Strong organizational skills, including ability to followassignments through to completion.
  
• Proficiency in PC skills such as Excel, Word, PowerPoint.
  
• Proven decision making capability with fullaccountability and responsibility.
  
• Demonstrated coaching skills.
  
• Excellent written and verbal communication skills.
  
• Demonstrated ability in problem solving and experience inmanaging Root Cause Analysis / Non Conformance /Deviation investigations.
  
• Experience in Sterile Drug Product Filling and start-upof same.
  
• Evidence of Continuous Professional Development.
  
• Evidence of Validation knowledge/experience.
  
• MES experience.
  
• Good knowledge of Lean / Continuous Improvement practicesand root cause analysis.
  

Behaviours:

• Always focused on the patient and customer needs.
  
• Resilient profile with the ability to deliver in achallenging environment.
  
• Ability to engage and manage multiple stakeholders toachieve the objective.
  
• Curious with learning agility.
  
• Operationally excellent, with attention to detail.
  
• Organised with systematic approach to prioritisation.
  
• Process orientated to achieve the business objective.