We have an immediate start for 12 month contract with Pharmaceutical / API Multinational Client in Co.Clare. Working straight days as part of QA team operating to cGMP in strict compliance with regulatory filing supporting all Site functions particularly Operations, Supply Chain, Engineering, QC and Tech Support.
RESPONSIBILITIES:
• Support QMS, and track deviations to ensure timely and accurate recordings leading to appropriate level of investigations using CAPA to ensure fully documented resolution & closure pre batch release
• Support QP in relation to all Batch release activity, with full review of Batch documents
• Maintain and report Metrics relating to Batch release
• Provide QA input into site wide Projects
• Support Change control to assist in evaluation pre-approval & post implementation, reviewing action item closure in project plan
• Ensure all PQRs are scheduled and tracked to meet regulatory standards
• Participate in Quality Audits both internal & external in line with cGMP
• Raise Quality Awareness at the site, & actively trend / monitor KPIs at Site level
• Review site SOPs to ensure conformity with Site and regulatory processes
• Validation & Qualification: Supporting process, cleaning and analytical validation; & equipment qualification – reviewing and approving valid documentation.
KEY SKILLS & COMPETENCIES:
• BSC in Chemistry, or related Science with 3-4 years QA experience in Pharm. (ideally API)
• Work to highest professional, ethical and moral standards to meet assigned deadlines
• Self- Starter, Positive Attitude and Excellent communicator
• Attention to detail and Project Orientated
• Sound Knowledge of QMS, cGMP
• Proficiency in MS Word, Excel, Powerpoint & Quality Software
eFlexes is an equal opportunity employer.
