QA Specialist II

A QA Specialist II is required on an initial 12-Month basis by CareerWise Recruitment for our Dublin-based multinational research-based pharmaceutical Company.

Role of this position

• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements as it pertains to a wholesale distribution operation
• Maintains routine programs and processes to ensure high quality products and compliance with current Good Distribution Practice (GDP) and Marketing Authorisations
• Supports the Responsible Person (RP) on site as well as working cross-functionally with warehouse and customer service personnel as well as facilities, EHS and validation colleagues
• Supports site operations from a QA perspective
• Participates in developing Standard Operating Procedures (SOPs) and other types of documentation to ensure quality objectives are met
• Reviews shipping records, environmental monitoring and associated data relating to distribution activities
• Works directly with operating entities to ensure that internal audits on site are conducted on a continuing basis to ensure compliance to GDP requirements
• Participate in preparation for and during internal and corporate audits as well as regulatory inspections of the site
• Participates in the development and delivery of training programs regarding relevant to site operations
• Conducts or serves as a coordinator of investigations and corrective and preventive action (CAPA) recommendations as well as Change Management related to site operations
• Conducts gap analyses and supports risk assessments of processes and procedures against relevant GDP guidelines as well as corporate standards
• Participate in local and corporate projects and process improvement initiatives, as required

JOB REQUIREMENTS

• Required Degree or Certification: BS desirable
• 4+ years of relevant experience in a GXP environment related field
• Experience in root cause analysis and deviation/CAPA support and review
• Technical writing and document (SOP, Work Instruction) update review and approval experience
• Change management support experience
• Experience in a GDP environment required

Please call Aisling O'Hagan-Yil today for further information on 021- 2427410 or email: aohagan-yil@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.