Associate Quality Specialist

4 weeks ago

Ireland PSC Biotech Corporation Full time
Associate Quality Specialist (Quality Systems)

Cork city, Ireland | Posted on 01/26/2024

  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 4-5 years
  • City Cork city
  • State/Province Cork
  • Country Ireland
Job Description

About PSC Biotech

Who we are?

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.

This position within the QA department willprovide Quality oversight, support and knowledge to activities relating toQuality Systems across the site and in meeting the priorities of:Compliance, Supply, Strategy and Profit Plan.

The team working style is one of collaboration, coaching and facilitation toensure the success of the site. The Quality Specialist is accountable for theQuality Systems within the site.

This role requires the delivery of a robust Quality Management System tosupport a flexible, collaborative, multi-skilled teamwork environment.

The Quality Specialist will have proven capability in development of QualitySystems as an active member, across cross functional teams, to deliver processimprovement. The Quality Specialist will model the Leadership behavioursand understand the MPS principles to drive a culture of continuous improvementbuilding a High-Performance Organisation.

The Quality Specialist will participate and comply with the QualityManagement System (QMS) requirements, including ownership as required.

Primary activities/responsibilities:
  • Required to be proficient in Quality approval and oversight forCommissioning and Qualification activities (IQ/OQ/PQ)
  • Provides to the site expertise in Quality Systems and/orOperational Quality, including the following i.e. QualityNotifications/Investigations/ Change Management; environment monitoringprograms; sterility assurance/low bioburden manufacturing; etc.
  • Uses knowledge to improve Quality Systems and/or OperationalQuality; solve complex problems, provide continuous improvement andexecute tasks.
  • Acts as a resource to colleagues with less experience in QualitySystems and/or Operational Quality
  • Understands and applies regulatory / compliance requirements totheir role together with remaining current on upcoming regulatory andcompliance changes
  • Interprets customer needs, assesses requirements and identifiessolutions to non-standard requests.
  • Makes decisions within guidelines and policies which impact ProductQuality, Projects and Quality Systems.
  • Uses knowledge to improve Quality Systems, solve problems, providecontinuous improvement, and execute tasks.
  • Provides compliance contribution to project teams and leads smallprojects.
  • Coaches and guides colleagues within the site.
  • Responds to non-standard requests from customer needs.
  • Makes decisions within guidelines and policies which impact ownpriorities and allocation of time to meet deadlines.
  • Supports Corporate Quality to ensure actions related to QualitySystems at the site are executed.
  • Participation in inspections of Site by Divisional / RegulatoryBodies / third parties together with follow up actions where applicable.
  • Participate in GMP Walkthroughs.
  • Deviation Management & Change Control approval.
  • Ensures supply of high-quality product through the implementationand oversight of the Quality Management System for the site.
  • Champion the highest Quality and Compliance standards for the site.
  • Ensure highest safety standards.
  • Additional activities as requested by QA Lead
Requirements
  • Degree or 3rd level qualification (Science, Quality).
  • Demonstrated knowledge in more than one pharmaceutical and/orchemical manufacturing operation.
  • 5 years’ experience in the pharmaceutical industry or a similaroperating environment which includes experience in a Quality function
  • Quality Assurance SME knowledge, from both operational andeducational experience, is required.
  • Knowledge and experience in interpreting current regulatoryrequirements and providing independent support to the site
  • Demonstrated ability to work independently and fully realizeimprovement initiatives with a moderate level of guidance.
  • Demonstrated ability to work and succeed within teams as well asleading small project teams.
  • Demonstrated ability to drive the completion of tasks.
  • Proven track record of providing independent Quality support to thesite.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Stakeholder management of multiple decision makers, auditors, crossfunctional teams by demonstrating the ability to maintain and strengthentrust relationships with people on all levels.
  • Proven decision-making capability with full accountability andresponsibility.
  • Energetic with proactive & positive attitude.
#J-18808-Ljbffr

  • Quality Operations Specialist

    4 weeks ago

    Ireland PSC Biotech Full time

    Dunboyne, Ireland | Posted on 01/01/2024 Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Dunboyne State/Province Meath Country Ireland Job Description About PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in...

  • Quality Specialist

    1 day ago

    Ireland PSC Biotech Corporation Full time

    Tipperary, Ireland | Posted on 05/10/2024 Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years Country Ireland Job Description About PSC Biotech Who we are? 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...

  • Associate Quality Manager

    4 weeks ago

    Ireland Stryker Corporation Full time

    Associate Quality Manager page is loaded Associate Quality Manager Apply locations Limerick, Ireland time type Full time posted on Posted 2 Days Ago job requisition id R518863 Work Flexibility: Onsite Will work within the Quality Operations structure, in a management capacity, has responsibility for quality related activities which includes, but not...

  • Quality Systems Specialist

    4 weeks ago

    Ireland 1484 McDermott Laboratories Limited Full time

    Quality Systems Specialist page is loaded Quality Systems Specialist Apply locations Northern Cross, Dublin, Ireland time type Full time posted on Posted 5 Days Ago job requisition id R5645774 McDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of...

  • Quality Systems Specialist

    4 days ago

    Ireland Viatris Company Full time

    Quality Systems Specialist page is loaded Quality Systems Specialist Apply locations Northern Cross, Dublin, Ireland time type Full time posted on Posted 12 Days Ago job requisition id R5645774 McDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of...

  • Quality Assurance Specialist

    4 weeks ago

    Ireland PSC Biotech Corporation Full time

    Industry Pharma/Biotech/Clinical Research Work Experience 1-3 years City Carlow State/Province Carlow Country Ireland Job Description About PSC Biotech Who we are? 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,...

  • Sr. Associate

    4 weeks ago

    Ireland eli lilly and company Full time

    Sr. Associate - Quality (Facilities, Maintenance, Utilities) page is loaded Sr. Associate - Quality (Facilities, Maintenance, Utilities) Apply locations Ireland, Limerick time type Full time posted on Posted 4 Days Ago job requisition id R-61263 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global...

  • Quality Control Specialist

    3 weeks ago

    Ireland PSC Biotech Full time

    Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Meath State/Province Meath Country Ireland Job Description About PSC Biotech Who we are? 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,...

  • Quality Assurance Specialist

    5 days ago

    Ireland C&C Group Plc Full time

    C&C Group plc is a premium drinks company which owns, manufactures, markets and distributes a unique portfolio of beer and cider brands in its home markets and across the globe. You probably know us best from brands like Bulmers, Magners and Tennent’s. About the role Our site in Clonmel is the home of Irish cider. And our Quality team are focused on...

  • Patent Litigation Associate

    4 weeks ago

    Ireland Hunter Savage Ltd Full time

    Patent/ IP Litigation Associate Solicitor | Dublin | Brand New Team: Are you an experienced Litigation Solicitor from a Life Sciences/ Patent background and keen on joining Ireland’s newest specialist Patent Litigation team? If so, please check out the job below and get in touch for more info… Role: IP/ Patent Litigation Solicitor Level : ...

  • Associate Supervisor

    3 weeks ago

    Ireland Australian Catholic University Full time

    An Associate Supervisor (End-user) is a specialist external to ACU who can provide expertise to the supervision of an HDR candidate and who will directly use or directly benefit from their research. An Associate Supervisor (End-user) supplements the supervision provided by the ACU Principal Supervisor and Co-Supervisor by bringing external expertise to the...

  • Associate Supervisor

    3 days ago

    Ireland Australian Catholic University Full time

    An Associate Supervisor (End-user) is a specialist external to ACU who can provide expertise to the supervision of an HDR candidate and who will directly use or directly benefit from their research. An Associate Supervisor (End-user) supplements the supervision provided by the ACU Principal Supervisor and Co-Supervisor by bringing external expertise to the...

  • Senior Specialist, Implementation

    4 weeks ago

    Ireland Mastercard Full time

    Senior Specialist, Implementation page is loaded Senior Specialist, Implementation Apply locations Dublin, Ireland Waterloo, Belgium time type Full time posted on Posted 2 Days Ago job requisition id R-214809 Our Purpose We work to connect and power an inclusive, digital economy that benefits everyone, everywhere by making transactions safe, simple,...

  • Payroll Specialist

    5 days ago

    Ireland Phoenix Recruitment Limited Full time

    Phoenix Search has partnered with an expanding enterprise in search of a meticulous and seasoned Payroll Specialist to integrate into their finance division. This individual will oversee global payroll functions and collaborate closely with our external payroll associates. As a pivotal member, the Payroll Specialist will uphold precision and timeliness in...

  • QA Associate

    5 days ago

    Ireland PSC Biotech Corporation Full time

    Industry Pharma/Biotech/Clinical Research Work Experience 1-3 years City Dublin State/Province Dublin Country Ireland Job Description About PSC Biotech Who we are? 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,...

  • Associate Sourcing Manager

    5 days ago

    Ireland Stryker Corporation Full time

    Associate Sourcing Manager page is loaded Associate Sourcing Manager Apply locations Limerick, Ireland time type Full time posted on Posted Yesterday job requisition id R519828 Work Flexibility: Hybrid or Onsite Associate Sourcing Manager Permanent contract, Limerick Job Summary The Associate Sourcing Manager will support the development and...

  • EHS Specialist

    3 weeks ago

    Ireland Abbott Laboratories Full time

    Abbott Ireland Nutrition Division – Cootehill This is an exceptional opportunity for a Safety Lead to further develop their career by joining a Global Leader in the Specialist Nutrition manufacturing industry and join the onsite Environmental, Health & Safety team (EHS); where they will play an integral role in managing and continuously improving Safety...

  • Clinical Nurse Specialist/Candidate

    5 days ago

    Ireland Suir Engineering Full time

    Clinical Nurse Specialist/Candidate (Specialist Palliative Care) Marymount University Hospital & Hospice Location: On site / Cork, Ireland job type: Permanent / Full-time Sector and subsector: Medical & Healthcare | Nursing & Midwifery Annual Salary Range: from € 57,198.00 to € 67,621.00 Grade Clinical Nurse Specialist/Candidate (General)...

  • Process Support Specialist

    4 weeks ago

    Ireland PSC Biotech Corporation Full time

    Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Carlow State/Province Carlow Country Ireland Job Description About PSC Biotech Who we are? 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,...

  • Process Support Specialist

    4 days ago

    Ireland PSC Biotech Full time

    Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Carlow State/Province Carlow Country Ireland Job Description About PSC Biotech Who we are? 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,...