...and regulatory filings
Acting as a liaison between QC, Process Analytical Sciences, and Manufacturing group to provide trending analyses to support various activities such as manufacturing investigations, and validation studies
Assisting in the implementation and...
...protocols, regulation, and schedule.
Can be involved in Supporting investigations into process variances according to site procedures.... ...such as Facilities, Process Development, Engineering, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control....
...management of quality instance closure.
Authors manufacturing investigations.
Reviews, edits and approves compliance records in... ...departments, such as Facilities, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control....
...the following areas: Upstream Sciences, Downstream Sciences, Analytical Technologies, IPC lifecycle, Data Analytics, Manufacturing Support... ...data collation
Performing data review of scientific investigations
Serving as a departmental liaison by providing data project...
...the processes are successfully transferred and also providing investigation support.
As a DP MSAT Engineer a typical day might include,... ...related to raw material/component procurement, equipment readiness, analytical process transfer, manufacturing document creation, etc....
...with members of Manufacturing, R & D, and Formulation to provide analytical support
Supervising QC Analysts and Shift leads -... ...approved test methods
Supervising or conducting laboratory investigations and generating reports in response to Deviations and OOS/OOT...
...and assuring timely completion of calibration related quality investigations
Acting as subject matter expert and presenting related topics... ...pharmaceutical or other cGMP environment preferred. Excellent analytical, negotiation, and interpersonal skills are required.
#LI-...
...Laboratory Systems in compliance with regulations and guidance
Investigating and resolving computer software and IT hardware issues with QC... ...of cross departmental levels
You have the ability to think analytically and learn quickly
You can manage Operational budgets
You...
As a QC Compliance Analyst you will support the QC organization in meeting compliance targets through laboratory investigation and deviation management. The Compliance Analyst will report quality system metrics to the group and identify improvements that can be made in all...
...calibration, etc
Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc
Participating in training of new employees and prioritizing workloads on a daily basis
Performing peer review of data...
£45.46k - £68.18k per annum
...Job Description:
Location: Singapore, Malaysia, Taiwan, Hong Kong, Macau, Thailand
Assist inspectors in investigating internal bribery, corruption, and other violations of company regulations.
Compile and analyze data from various business sectors within the group,...
Remote job
...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 anomalies, as well as safety incidents
Implementing corrective/...
...transfer of methodology from other test facilities
Maintaining laboratory reagents, media and supplies
Conducting laboratory investigations and generating reports in response to invalid assays, Deviations, OOS/OOT
Initiating and completing CAPAs and Change Controls...
...process data and review methods, facilities and equipment design to ensure operational and process consistency
Support quality investigations and technology transfer initiatives as a subject matter expert
Work effectively and efficiently in a team-oriented environment...
...accordance with current Good Manufacturing Practices (cGMP).
Collaborates with cross functional teams to resolve issues, complete investigations and maintain compliance.
Responsible for QA review and approval of the following types of documents:
- Failure...
...for impact to the qualified state for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
Reviews,...
...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 incidents
Implementing corrective/preventative actions for...
...review and approval of the following types of documents, relating to area functions: Master records / executed records / failure investigations / CC / SOPs / validation protocols and summary reports / incursions
Approves various documents relating to area function, including...
...Attends routine MFG and deviation meetings
Authors Process Validation protocols and report
Performs product impact assessments
Investigates OOS and OOL IPCs
Data mining and retrieval for colleagues for quality investigations
Serves as liaison between Rensselaer and...
...safe working 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...
£ 80 - 227 per week
...work.
Proficiency in the use of statistical analysis software and qualitative research tools.
Excellent English language skills, analytical and critical thinking skills, and writing skills to clearly report research findings.
Real-time knowledge and integrity of the...
Remote job
...Coordinating logistic documentation enabling shipments
Driving compliance activities including but not limited to, changing controls, investigations and CAPA’s
Managing audit CAPA closure
Maintaining, updating and providing the status of activities via schedules and...
Within this role you will be performing all compliance related tasks necessary to complete investigations and implementation of robust corrective actions for supporting manufacturing and site operations. Providing compliance expertise throughout the Engineering, Automation &...
...in a compliant state by executing change control requests
Collaborating closely with laboratory personnel
Participating in investigations and root cause analysis
Adhering to relevant system software SOPs and policies
Supporting system validation and qualification...
...work.
Proficiency in the use of statistical analysis software and qualitative research tools.
Excellent English language skills, analytical and critical thinking skills, and writing skills to clearly report research findings.
Real-time knowledge and integrity of the...
Remote job
...Authorises significant deviations to established, approved procedures, provides guidance to assist co-workers with troubleshooting investigations and problem resolution.
Ensures safety and operational standards are maintained.
Education and Experience:
Third level...
...international situation and information policy.
2. Analyzing and prejudging the international situation in the South China Sea and writing analytical reports.
Benefits:
For each project you work on, you can expect compensation ranging from $800 to $3,000, reflecting your deep...
Remote job
...of equipment/process/schedule disruptions
Triage of potential non-conformances including securing necessary documentation for investigation team in real-time
Supporting of/counter signing annotations
Performing area walkthroughs
Providing oversight and review of...
£34.09k - £56.82k per annum
...Excellent communication and interpersonal skills
- Capability to work independently and collaboratively within a team
- Strong analytical and problem-solving skills
- Proficiency in Microsoft Office Suite
- Experience participating in European Expo shows (preferred)...
...areas of responsibility
Providing technical expertise and leadership with respect to cGMP across manufacturing, quality systems, investigations, batch review, product technical transfer, and other areas, as required
Interacting with critical biotechnology commercial and...