Search Results: 74 vacancies
...and preparing technical reports.
· Execute run the business activities e.g. equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
· Provide support during commissioning phase by reviewing and approving documents...
...Continually seeks to drive improvements in product and process quality.
Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
Evaluates new equipment and processes and participates in the transfer of new products....
...patient risk.
Supports the planning pipeline of quality improvement activities including initiatives to increase product quality, NCR & CAPA resolution, reduce cost, decrease in-efficiencies and improve risk management
Oversight and responsibility to ensure site maintains...
...reach consensus and ensure document approval timelines meet business needs.
Own and/or support GMP document-related Change Controls/CAPAs.
Skills Brief:
Strong knowledge of Good Documentation Practices (ALCOA), ISPE Standards,GAMP5, and Documentation Management/Life...
...release.
Collaborate with production to handle product disposition.
Execute QMS activities like non-conformance investigations, CAPA, change control, complaints, document control, and record retention.
Foster awareness of customer requirements within the company....
...for example CSV and SDLC.
• Support the review & approval of key quality deliverables including SDLC, Change control, Deviations, CAPAs. Etc.
• Attend periodic review meetings, cutover migration, hyper care support, any enhancements planning, design and/or implementation...
...inventory and cycle counts
Participating in the Supplier Corrective Action Request (SCAR) program
Participating in NOE’s, EOE’s, or CAPA’s as required
May be required to write SOPs
May interact with vendors, contractors, etc
Following established safety practices...
The QC Compliance Specialist will be responsible for managing QC's Change Controls/CAPAs and Workflows.
In this role a typical day might include, but is not limited to, the following:
Coordination and documentation of QC quality records including but not limited to, Change...
...organization
Supporting the EHS incident management process on site; Managing EHS incidents to closure, including root cause analysis and CAPA management
Identifying, implementing and tracking corrective actions to prevent recurrence
Coordinating internal EHS auditing and...
...with Operations and the business functions to ensure quality performance of product and processes.
~ Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
~ Lead and participate in the development of the internal Lab focusing...
...Conducting laboratory investigations and generating reports in response to invalid assays, Deviations, OOS/OOT
Initiating and completing CAPAs and Change Controls in accordance with site procedures
Writing new and updates current SOPs as needed
Providing training to...
...customer/regulatory inspections
Proactively identifying and implementing lab process improvements and lean initiatives
Ensuring that CAPAs and Change Controls are initiated and completed on time and in accordance with site procedures
Training, developing and mentoring...
...inspection of vendor and internally manufactured implants for development or investigative purposes
Metrology support for complaints, NC and CAPA investigations
Inspection and calibration of internal and vendor custom gauging
Being able to challenge Vendor and Internal...
...Supports in the development and upgrade of engineering procedures, template, and forms, to ISO9001 and en1090 standards.
May own and lead CAPA and NCE activities.
Role Requirements:
A degree in a relevant engineering subject is required.
Minimum of 5 years’ experience...
...with the creation/updating of GxP Documents
Provides Technical Writing assistance with the management of Change Controls, Deviations, CAPAs
Provides Technical Writing assistance with the completion of System Periodic Reviews.
Supports the execution of System Audit...
...departmental initiatives where applicable.
· To assist in laboratory investigations as required, in particular Quality Issues, deviations and CAPAs, to help meet specifications and quality timelines.
· To foster a culture of Lean and Continuous improvement within the department...
...Responsible for QA review and approval of the following types of documents: Failure investigations / Corrective and preventative actions (CAPA) / Standard operating procedures (SOP’s) / GxP documents / Change control documents
Reviews various system records for assignment,...
...are not limited to, the following:
Completes investigations of technical deviations for department issues of non compliance. Ensures CAPAs are identified as appropriate and are implemented as planned; in addition, ensures CAPAs have the intended effectiveness.
Acts as a...
...accordance with Hovione internal procedures.
Timely devise and implement effective and efficient corrective actions / preventive actions (CAPAs), as appropriate.
Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals....
...devices in terms of complaint investigation and risk analysis.
Participate in engineering projects in any one of the following areas - CAPA, Design, Manufacturing, EHS or NPI.
Collaborate with other Engineering teams to ensure the effective completion of all activities...
