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...
...The overall purpose of the post is to put in place and provide clinical leadership and pivotal service for the Young Adults Disability Team... ...Adult Disability Team
Please note the base for the post may change within Community Healthcare Mid-West. Community Disability...
...performing tasks supporting the manufacturing operations of both clinical and commercial manufacturing programs at Regeneron Ireland.... ...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...
...Driving compliance activities including but not limited to, changing controls, investigations and CAPA’s
Managing audit CAPA closure... ...2 years of related experience in cGMP manufacturing operations (clinical and/or commercial External Manufacturing) or equivalent combination...
...and regulatory expectations. Individual will play a major role in the commercial operation while remaining adaptable to the changing needs of the clinical programs.
Essential Duties and Responsibilities include, but are not limited to, the following:
Organizational...
...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...
...good understanding of current CMC RA worldwide regulations
• Experience in delivering CMC/CP sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for biologic products / combination products
• Experience in dealings with...
...Responsible to ensure that licensed product is certified and released to market in compliance with commercial manufacturing license and clinical (IMP) products in accordance with EU directive 2001/83/EC, 2004/94/EC and in accordance with the requirements.
Essential Duties...
...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...
...:
Resource competition in the Arctic is a concern for many countries and involves many aspects, such as military security, climate change and environmental protection, sustainable economic development, and international cooperation and governance, which will affect policy...
Remote job
...master manufacturing records (MRs), standard operating procedures (SOPs) and other documentation needed to successfully complete required clinical and commercial external manufacturing activities
Supports and informs critical initiatives and contract negotiations that drive...
...investigations, batch review, product technical transfer, and other areas, as required
Interacting with critical biotechnology commercial and clinical API manufacturing operations, facilities to ensure a successful compliance profile
Defining and implementing quality standards,...
...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,...
...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’...
...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...
...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...
...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...
...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...
...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...
...:
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...
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...
...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,...
...for existing equipment and maintenance processes
Preparing engineering evaluations and testing plans for and executes modification change control documentation
Interpreting P&IDs, equipment/system layouts, wiring diagrams and specifications in planning and performing maintenance...
...user departments on format, style, and architecture of documents to enhance standardization and clarity, and to minimize unnecessary changes
Training departmental staff in procedures and cGXPs, as well as training user departments in the documentation systems as needed...
...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....