Within this role you will be responsible for the commercial Manufacturing Documentation team. Facilitate and coordinate Manufacturing records review to meet batch disposition timelines, preparation and review of Cleaning Verification Packs, PRIMR data entry and management of...
Within this role you will be responsible for managing and overseeing Document Control and Archives operations. This includes oversight of the following: document workflows, records issuance, paper and electronic records archives, inspection support, projects, and metrics....
...Summary: Provides support to the process for creating, reviewing, approving, distributing, controlling and maintaining documentation to ensure effective and efficient application of GMP.
Documentation within this process includes, but is not limited to, manufacturing and...
...The primary function of this role is to ensure regulatory adherence of Cook Medicals
document control process.
Reporting to: Manager, Quality Systems
~• Change Analyst within the Agile Product Lifecycle Management (PLM) system. • Processing and GMP / GDP review of...
...political topics such as foreign relations and political ideology.
2. collecting data from a variety of sources, such as government documents and military cooperation news.
3. interpreting research results using statistical analysis tools.
4. predict political, social,...
Remote job
...input into Manufacturing records, batch sheets and procedures.
Writes, reviews, Standard Operating Procedures or other controlled documents as needed.
Provides technical input to resolve process problems both on and off the production suites
Work closely with other...
...manufacturing/utility equipment in a clean room environment
Perform daily Work Orders and PMs and efficiently coordinate the workflow and documentation of PMs and WOs
Troubleshoot the electrical equipment during off-nominal conditions; locate the source of trouble and make/...
...Specifications for new equipment and update old equipment SRS/ SIA. Defining standards, controls, and procedures across the lifecycle of documents.
Contact external vendors to come on site, organize induction, organize safe permit for work and supervise and approve vendor...
...Production (Downstream Operations) a typical day may include, but are not limited to, the following.
Responsible for ensuring that all documentation (SOPs, Manufacturing Records, Batch Sheets & Logbooks) is current, accurate, reviewed and in accordance with regulatory...
...to, the following:
Complying with site safety policies and striving to maintaining an accident free environment
Ensuring documentation of maintenance activities to cGMP’s standards both in paper based records and the Computerized Maintenance Management System (CMMS...
Within this role you will be responsible for the receipt, documentation, and movement of inventory and non-inventory items within the plant and from outside sources. This position also performs labeling and shipping functions as needed.
This is a temporary contract and a...
£ 2,273 - 2,500 per month
...time
Job Description
As a member of the translation team, you will work on the official English translations of central government documents. This includes the premier’s annual government work report, national policy documents, and the works of Chinese leaders.
Your main...
...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 Control’s /CAPA's and Workflows
Coordinating cross functional teams...
...Owning and continuously improving the batch review activities to support batch disposition of Regeneron Products
Overseeing Ireland Document Control (DC) operations and directing the activities of the DC management team
Ensuring alignment is maintained and achieved...
...notifications, deviation investigations, and corrective actions.
Reviews, edits, and approves change controls, SOPs, reports and other documentation.
Coordinates with other departments or outside contractors/vendors to complete validation tasks.
Collaborates with...
...drawings
Developing Process Flow Diagrams for manufacturing processes
Supporting QA Validation department by preparation of design documents and assisting in protocol execution
Assisting in investigations of process equipment, utility systems, and control system...
...state of the Israeli-Palestinian conflict.
- Exceptional writing skills, capable of producing clear and logically structured research documents.
- Prior relevant work experience will be given priority in the selection process.
- Ability to work independently with strong...
Remote job
...manufacturing activities are compliant with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.
Essential Duties and Responsibilities include, but are not limited to, the following:
Responsible for all aspects of QA Team...
...Building effective relationships with other departments and functions within the organization
Compiling, reviewing and approving documentation
Driving continuous improvement initiatives/programs
May support the site through regulatory audits by providing technical...
...company’s quality program.
In this role a typical day might include, but is not limited to, the following :
Gathering data and documenting test results
Reviewing test results to ensure compliance with standards; reporting any quality anomalies
Complying with all...
...in the design review, site acceptance and installation of equipment
Supporting QA Validation department by preparation of design documents and assisting in protocol execution
Assisting in investigations of utility systems, and control system anomalies as well as safety...
...resolve issues, complete investigations and maintain compliance.
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...
...Aligning with site Environmental, Health and Safety policies and striving to maintain an accident free environment.
Ensuring documentation of maintenance activities to current GxP standards both in paper based records and the computerized maintenance system.
Maintaining...
...reporting project milestones related to raw material/component procurement, equipment readiness, analytical process transfer, manufacturing document creation, etc.
Reviewing and approving cGMP batch documentation (e.g. master batch records, component specifications, validation...
..., troubleshooting proactively and solving complex problems
Experiencing review requirements, specifications and technical design documents to provide timely and meaningful feedback
Producing detailed documentation to a high standard
This role might be for you if:...
...provides MES configuration and support services to meet end-user needs. Additionally, the individual processes system change controls, documents and maintains configurations to ensure that the MES remains in a validated state.
As a Senior MES Operations Analyst , a...
...environment
Assuring compliance with all regulatory requirements as related to equipment maintenance functions
Investigating and documenting procedural and operational deviations
Working closely with Operations, Systems Support, and Qualify functions to ensure...
...of the team to ensure project deadlines are met.
Adhere to all safety regulations and guidelines.
Complete all required documentation accurately and on time.
Requirements:
Qualified Electrician with a valid electrical certification
Minimum of 3 years...
...Independently leading non-conformance investigations to prevent reoccurrences
Reviewing Equipment Drawings, Schematics, Life Cycle Documents, and Automation programming
Reviewing SOPs, Work Instructions, Batch Sheets, Manufacturing Records and Logbooks in accordance...
...activities associated with the manufacturing process
Supports technology transfer activities as needed
Reviews Manufacturing documentation associated with the transferred process
To be considered for this opportunity you should have a BS/BA in Life sciences/...