Senior QA Specialist
Berkley Group
- Dublin
- Contract
- Full-time
Responsibilities:
- Accountable for Quality oversight of processes and procedures related to IS, CS & Automation compliance (ex: BMS, PCS, FMS, HMI upgrades etc..)
- Quality review and approval of C & Q documentation
- Review of Risk Assessments, DS, URS & QRAES documents
- Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
- Review of executed validation documents and reports
- Perform all activities in compliance with safety standards and SOPs
- Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
- Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
- In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the roleBasic
- University degree. Science or Engineering related discipline preferred.
- Relevant experience (7 yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing quality direction of introduction of automation / IS projects
- Ability to work independently and remotely with minimum direct supervision.
- Critical thinking skills.
- Strong organisational, communication, coordination, and meeting facilitation skills.
- Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.
- Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.