We are currently looking to fill a Quality Compliance Specialist - Change Control position on the Quality Assurance Change Control Team. This role works within the QA Change Control Team to primarily facilitate activities and relationships regarding change controls and partner...
...experiments, control charts
You demonstrate an ability for designing and implementing SPC and DOE programs
You are open and receptive to change while looking for opportunities to continuously improve processes
You are able to multi-task within challenging timelines
You...
...skills to ask questions and adapt quickly
You can adhere to the letter and spirit of policies and regulations
You can adapt to a changing environment and have the ability to adhere to a process-driven schedule
To be considered for this opportunity you must have a...
...practices and documentation.
Participating in other quality systems activities such as internal audit, inspection preparation and change control as required.
Collaborating with subject matter expert(s) and Learning Design Specialist, may develop training materials for...
...skills, organizational skills, with a focus on attention to detail essential.
Able to prioritize, re-prioritize as needed and adapt to change, whilst maintaining deadlines.
Comfortable in ambiguous environment and ability to translate ambiguity into actionable steps....
...investigations/deviations relating to QC operations including: NOE, EOE and DNFA, GLIF investigation, corrective and preventive actions, change control and standard operating procedures
Reporting quality system metrics to the group and other QC functions
Conducting cross...
...involved in Supporting investigations into process variances according to site procedures.
Communicates well with supervisors regarding changes to the process or material used within the process.
Interfaces with other departments, such as Facilities, Process Development,...
...equipment that has become obsolete
Writing and executing test plans and technical evaluations to demonstrate instrument suitability for change control documentation
Supervising engineering contractors
Maintaining company reputation by enforcing compliance with regulatory...
...conditions; locate the source of trouble and make/arrange for all necessary repairs; this includes generating and completing critical systems change control and interact with and oversee contractor/vendor work
Adhere to and remain current in assigned IOPS plant and department...
...multi-task and priorities within set timelines
You have strong written and oral communication skills
You are open and receptive to change while looking for opportunities to continuously improve processes
To be considered for this opportunity you should have a Bachelor’...
...working closely with functional departments on projects developing, implementing and enhancing the system
Processing IT Applications change control requests
Working with Validation and Quality departments ensuring IT Applications are implemented following development...
...market dynamics.
Individual who is experienced operating with integrity, focus, and clarity in an environment of ambiguity to drive change and improvement.
Demonstrated success supporting the global supply market evaluation process using all available market...
...Job Details
listing title: ULHG005824 - Change and Transformation Lead - Clinical Midwife Manager 3
Listing reference: ULHG005824
Job Category: Nursing & Midwifery
Grade: 2133 Clinical Midwife Manager 3
HSE Area: University of Limerick...
...preventative actions for existing equipment and manufacturing processes.
Prepares engineering evaluations for and executes modification change control documentation.
May supervise mechanical, electrical, and automation contractors.
Maintains a clean and safe working...
...assessments
Data mining and retrieval for colleagues for quality investigations
Serving as liaison between Rensselaer and Raheen for Change Notification
Developing and writing protocols for manufacturing support activities
Presents findings at group and possibly at...
...administration activities to ensure overall good health of the Quality Management System (QMS). This position will focus on Deviation, CAPA, Change Control and Quality Risk Management elements of the QMS.
Essential Duties and Responsibilities include, but are not limited to, the...
...courteous manner.
To promote good communications within your team so that all staff are aware of the business within the hotel any change, standards of service etc.
To set a good example for the staff with regard to punctuality, attendance, attitude and hygiene.
To...
...Microsoft Word, Excel, PowerPoint, and Outlook
You demonstrate an ability to work within a successful team
You can adapt to a changing environment and have the ability to adhere to a process-driven schedule
To be considered for this opportunity you should have a...
...:
Strong knowledge and understanding of equipment used for QC analysis and operations.
Strong background and familiar with site change control, risk management and data integrity initiatives/programs.
Strong knowledge and understanding of EU annex 11 and FDA 21 CFR...
...regulatory requirements and current industry standards, ensures expectations and procedures are followed, and ensures deviations and changes, if any, are documented and assessed in accordance with IOPS processes and procedures.
Works in and on the business; translates ambiguity...
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...
...functionally and cross site to reach agreement where needed.
Tracks quality system metrics including deviations, corrective actions and change controls.
Ensures audit readiness and coordinates where required.
Performs people management duties including time sheet...
...Continually reassess’ Global Procurement systems and processes for adherence to cGMPs and industry standard methodologies and implements changes/improvements as needed.
Represents the Global Procurement department on various topics during regulatory inspections, and...
...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 other analysts...
...Failure investigations
- Corrective and preventative actions (CAPA)
- Standard operating procedures (SOP’s)
- GxP documents
- Change control documents
~ Reviews various system records for assignment, compliance, and closure.
Provides administrative support of...
...that support Industrial Operations and Product Supply (IOPS). The analyst will work with the business to deliver analytic solutions that change the way work is currently performed and be able to effectively communicate compelling data stories to leaders across the business....
...consultation or advice in alignment with QA policies
Representing Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc. including active participation in investigation, evaluation, and problem resolution
Representing the IOPS...
...equipment
Following current good manufacturing practices (cGMPs)
Troubleshooting process equipment problems and making required changes
Supporting equipment investigations to drive reliability and performance
Ensuring all areas of responsibility are compliance with...
...process is operating within intended process control strategy and within cGMP operations
Authors policies, technical reports/protocols, change controls, etc. in support of cGMP activities
Supports development of sampling plans for GMP batches related to lot release,...
...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 direct...