cGxPServe

Roles & Responsibilities: Quality Management Systems (QMS). CAPA. internal/external audits. QMS function NCMR. Supplier Controls. Management Review Risk Review. Quality Systems. CAPA. Internal Audit. metric reporting and process improvement initiatives. strong background in medical d المزيد...

Job Description: Reporting to the Medical affairs (MA) this role defines work roles and oversees human factors user experience and preclinical activities for direct reports and extended core-team team members. Ensures MA function has necessary skills and resources to execute on develo المزيد...

Job Description: The Quality Control Operations (QCO) Analyst III Contractor plays a crucial role in supporting the departments efforts to maintain the highest standards of quality and compliance from development through to commercialization. In addition to executing routine and non- المزيد...

Job Description: Execute assembly instructions per Batch Record requirements for Packaging and Labeling processes in compliance with cGMP guidelines. This will require on time and neat documentation during the execution to assure compliance. Provide support to the Manufacturing Group المزيد...

Job Description: We are seeking a detail-oriented and dependable Part-Time Laboratory Technician to support our laboratory operations. This entry-level position is ideal for a recent graduate or early-career professional with a background in Biology or Biotechnology. The technician wi المزيد...

Responsibilities: Your primary responsibilities will be to effectively organize and lead cross-functional project teams using your project management skills . Using your strong planning organization communication and collaboration skills you will lead a diverse scope of projects with المزيد...

Job Description: Provides clerical and administrative support related to documentation processes and systems. Creates logbooks and other control issued documents. Assists in maintaining the document archival room. Responsible for filing and maintenance of controlled documents and reco المزيد...

Roles & Responsibilities: Develop and execute validation protocols for computer systems. Ensure compliance with regulatory requirements and industry standards. Create detailed validation documentation including plans reports and scripts. Conduct risk assessments and impact analyses r المزيد...

Roles & Responsibilities: Good manufacturing practices (GMP) CAPA/NC Statistics DFMEA PFMEA CAD Root Cause Analysis Manufacturing Process. GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs. Strong creative analytica المزيد...

Overview: We are seeking a skilled and proactive IT Incident & Service Management Analyst to support application incident escalations trend analysis and service operations in a remote environment. This role requires a strong background in incident management regulatory awareness and c المزيد...

Job Description: Support the design quality assurance of capital equipment medical devices through FMEA development risk documentation and process compliance. Responsibilities: Generate Design Process and Use FMEAs for capital equipment medical devices. Create risk management plans a المزيد...

Job Description: The Associate QC Scientist performs laboratory testing within a fast paced GMP environment in support of one or more of the following areas; raw materials in-process product final Bulk product stability and/or validation. Analyzes test data and evaluates results. Writ المزيد...

Responsibilities: Maintains all qualified and validated equipment and systems in compliance with policies guidelines and procedures. Support Lifecycle Document Management System. Develops protocols and associated reports while adhering to a change management process. Supports the exe المزيد...

Responsibilities: Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies manufacturing techniques as well as production yields for exist المزيد...

Roles & Responsibilities: Company focusses on Health Care products Initiate and implement cost improvement plans on new and existing programs. Perform Validation (IQ OQ PQ) in accordance with companys SOPs Contribute to the design and development of components assemblies and devices. المزيد...

Responsibilities: Serves as lead programmer for assigned projects to provide statistical and programming support in one or more Phase I-III clinical studies. Design and perform quality checks on analysis datasets tables listings figures (TFL) and written reports to support clinical t المزيد...

Job Description: *Will be responsible for translating the current state (as-is) business processes performed within our existing Product Lifecycle Management (PLM) system across various global design and manufacturing sites. You will then work closely with subject matter experts and t المزيد...

Roles & Responsibilities: Validation Planning: Develop/update Master Validation Plans (MVP) and individual Validation Plans (VP) for system changes. Required: Proven expertise in CSV (Computer System Validation) methodologies (e.g. GAMP5) FDA regulations (21 CFR Partas applicable) an المزيد...

Job Description: Carries out the practical work in the laboratory including method development method validation and trouble shooting. Takes over responsibility for the QC part of projects. Perform required testing on raw materials intermediates and finished products. Support QC chemi المزيد...

Responsibilities: Work with Supplier functions to develop PFMEA Control plans and statistical plans (Cpks). Ensures that project and/or process control documentation is compliant with requirements and/or contract. Experience advancing Zero Defect culture utilizing advanced Quality to المزيد...