Website Aequor Technologies LLC
Aequor Technologies LLC
Company : Aequor Technologies LLC
Note:
Fully Onsite
Standard Working Hours (Dayshift)
-this is an on site position so will need to be able to be onsite.
-need to be able to gown in, and/or wear construction gear and steel toe boots.
The QA will provide quality support and oversight of the commissioning & qualification and process qualification of the facility, utilities, computer systems and equipment. They will collaborate cross-functionally to ensure project timelines and milestones are met.
Primary Responsibilities:
" Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance.
" Perform quality review of documents to support facility commissioning and qualification, according to project timelines.
o Commissioning / Qualification Protocols
o Performance Qualification Protocols (PQ)
o Review and Approval of protocol discrepancies
o Review of Final Reports and Summary Documents
" Provide quality support during execution of commissioning and qualification testing, reviewing and approving changes and discrepancies, as required.
" Ensure that all activities & related documentation for facilities, equipment, materials, and processes comply with applicable regulations and *** requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
o Ensure documents comply with *** s procedures, regulatory expectations (e.g., FDA, EMA), and Good Documentation Practices (GDP).
" Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies.
" Participate in meetings related to document planning, execution, and issue resolution.
" Escalate any compliance concerns or critical gaps to QA management.
" 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 role.