Qa Validation Specialist
3 weeks ago
The successful candidate will ensure the site has a strong operational compliance focus aligned with the principles and expectations of c GMP regulations.
Key Responsibilities: Lead, facilitate and/or participate daily on cross-functional teams to collaboratively actively to address compliance issues and achieve project milestones.
Participate in investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented timely.
Participate in project teams through all phases of projects - conceptual and detailed design, equipment procurement, construction, installation, start up, commissioning and qualification, and system release.
Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility.
Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial/clinical operations at the facility.
Review and Approval ofvalidation lifecycle documents and reports.
Quality oversight of computer system validation activities for life cycle approach in accordance with good automation practices, DQ, IQ, OQ, PQ and PV following validation plans and complying with c GMP and company procedures.
Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems, identifying and implementing appropriate updates where required.
Assist in the creation and maintenance of QA policies, SOPs and reports in line with site requirements.
Participate in and support risk management activities in line with relevant guidance and best industry practice.
Assist in the execution of the internal audit programme including the performance of audits are required.
Qualification and Experience: Postgraduate qualification in an engineering or science discipline would be advantageous(Science/Quality/Technical).
Min 5 years experience, ideally in Quality Assurance / Validation within the Biological and/or pharmaceutical industryas part of a computer systems validation, validation, engineering or IT/OT function.
Experienced in the execution of commissioning and qualification/validation of computerized systems and process equipment (e.g.
bioreactors and process vessels, chromatography, ultrafiltration, autoclaves, parts washers).
Knowledge of GAMP requirements to the qualification and validation of computerised systems a distinct advantage.
Experience supporting complex investigations and problem-solving techniques.
Project Manager capability with significant understanding of Power BI.
Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME.
Strong written and verbal communication skills.
Experience in quality management systems such as Veeva Vault, SAP, Trackwise, KNEAT, etc.
Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
Experience in direct interactions with regulatory agencies during site inspections Skills: Validation CSV QA Biotech GMP
-
QA Validation Specialist
2 weeks ago
Dublin, Dublin City, Ireland Tandem Project Management Ltd. Full timeSummary:A QA Validation Specialist is required for a biopharmaceutical company in Dunboyne. The incumbent will be responsible for maintaining cGMPs for assigned areas in conformance with policies and procedures in compliance with cGMPs, Health Agency regulations and all other applicable governing regulations.Responsibilities:Lead, facilitate and/or...
-
Operations Specialist
5 days ago
Dublin, Dublin City, Ireland QA Full timeMid-Senior level Not discloses Ireland Dublin, County Dublin, Ireland20 hours agoThe role:PE Global is currently recruiting for a QA Operations Specialist on behalf of a leading biotech company based in Dublin North. This is an initial 11-month contract and a 4 cycle shift position.• Shift will be 4 days on, 4 days off with 12 Hour Shifts (7am -...
-
QA Systems and Validation Specialist
2 weeks ago
Dublin, Dublin City, Ireland DPS Group Global Full timePosition Description:The QA Systems and Validation Specialist will be responsible for:Assessment of changes for GMP compliance in accordance with site change control procedure for facilities, utilities, lab and manufacturing equipment and control system changes.Review and approve the GMP design aspects of major capital projects including new facility...
-
QA Specialist
2 weeks ago
Dublin, Dublin City, Ireland Life Science Recruitment Ltd Full timeQA Specialist (Shift days) RK23461 Contract 11 months Dublin Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. This role involves The Quality Assurance...
-
QA Specialist
6 days ago
Dublin, Dublin City, Ireland Life Science Recruitment Ltd Full timeQA Specialist (Shift days) RK23461 Contract 11 months Dublin Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. This role involves The Quality Assurance...
-
Qa Specialist
2 weeks ago
Dublin, Dublin City, Ireland Life Science Recruitment Ltd Full timeQA Specialist (Shift days) RK23461 Contract 11 months Dublin Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin.This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.This role involves The Quality Assurance Specialist...
-
Qa Specialist
1 week ago
Dublin, Dublin City, Ireland Life Science Recruitment Ltd Full timeQA Specialist (Shift days) RK23461 Contract 11 months Dublin Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin.This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.This role involves The Quality Assurance Specialist...
-
QA Specialist
5 days ago
Dublin, Dublin City, Ireland Scientificjobs Full timeQA Specialist (Shift days)RK23461Contract – 11 monthsDublinWe're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.This role involves The Quality Assurance...
-
Qa Senior Specialist
4 days ago
Dublin, Dublin City, Ireland Cpl Resources - TEG Full timeQA Senior Specialist Permanent Swords, Co.Dublin.ABOUT US? SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland.We are part of SK Inc., a Korean company with revenues of $99 billion in 2023.Our mission is to produce and deliver life-changing therapies that...
-
CQV Specialist
1 week ago
Dublin, Dublin City, Ireland beBeeProcessValidator Full time**Job Title:** CQV Specialist - Process ValidatorCQV specialists play a vital role in ensuring the smooth operation of our pharmaceutical facilities. As a CQV specialist, you will oversee the commissioning, qualification, and validation (CQV) processes for facility expansions.The successful candidate will ensure compliance with quality and regulatory...