cGxPServe

Job Description: We are seeking a Packaging Operator to execute packaging and labelling processes per Batch Record requirements in accordance with cGMP guidelines. This role includes documentation cleaning equipment setup and collaboration across departments to maintain production com More...

Roles & Responsibilities: Lead PFMEA activities with cross-functional teams. Participate in DFM and DFA for new product development. Develop manufacturing assembly and test methods. Requires a bachelors degree. Must have experience in the medical device field. Requires 5 years in an More...

Responsibilities: Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Creates revises and implements quality standards as well as procedures i.e. Standard Operating Procedures (SOPs) etc. for Erbe USAs Quality Management Sy More...

Responsibilities: Providing statistical programming support to generate tables listings and figures for assigned projects. Demonstrating proficiency in CDISC SDTM and Adam to support various submission activities including IA CSR DSUR and publications. Overseeing all aspects of stati More...

Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe support of international product registrations and related regulatory affairs activities including execution of procedures and More...

Responsibilities: Support day-to-day medical device manufacturing operations ensuring compliance with FDA QSR and ISO 13485 standards. Lead and execute equipment qualifications (IQ/OQ) and process validations (OQ/PQ) including cleaning and upgrade validations. Perform process charact More...

Responsibilities: Lead and manage change control processes for S/4HANA implementation in alignment with GxP and related SOPs. Review project timelines to ensure sufficient time is allocated for GxP validation activities and documentation deliverables. Prepare and maintain validation More...

Responsibilities: Maintain and update EDC user access across multiple clinical studies. Track and manage user access requests in coordination with CRAs and EDC vendors. Curate and maintain standardized tracking spreadsheets for both internal and external use Transfer verified data fr More...

Responsibilities: Responsible for performing various Quality Engineering activities whose main purpose is to facilitate continuous improvement for both products and processes and to support new product/process development activities. These activities include process validation defect More...

Job Description: We are seeking a Systems or Quality Engineer to be responsible for integrating design procedures templates and guidance documents within our ISO 13485 compliant Quality Management System (QMS). The successful candidate will have a working knowledge of FDA/ISO regulati More...

Roles & Responsibilities: Manufacturing Expert with good process knowledge. Work closely with R&D team and define the manufacturing process that more suites for the process for the NPI programs. Come up with cost optimization ideation and ease the manufacturing process. Guide the More...

Job Description: Seeking a Contract Scientist to support the siRNA group within the Biotherapeutics and Genetic Medicine (BGM) department. This temporary position offers the opportunity to contribute to the design and execution of cutting-edge experimental approaches to address key sc More...

Roles & Responsibilities: Bachelor of Science Degree from accredited institution in Manufacturing Engineering Mechanical Engineering Industrial Engineering or a related degree. Master of Science Degree from an accredited institution in Manufacturing Engineering Mechanical Engineerin More...

Job Description: The Business/Data Analyst (Analyst) is a key contributor to the Data Analytics team. The analyst synthesizes and leverages datasets based on applied modelling and analysis of data sources with process knowledge of all the key processes in client Complete Access parti More...

Roles & Responsibilities: Candidate must have understating on latest regulations i.e. 21CFR Part 11 EU annex 11 and Guidelines e.g. GAMP5 guide. Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Well versed with Manufacturing Quality More...

Responsibilities: Lead and manage the Process Validation and Verification qualification at the plastic suppliers and other commodities across IGTD portfolio. Looking to hire somebody with Manufacturing Engineering and Design expertise to review the Specification of Product and Part r More...

Job Description: The Manufacturing Engineer I is an entry-level position responsible for supporting manufacturing engineering to ensure efficient manufacturing processes. Engineering services may include value stream management A3 problem solving process development project management More...

Responsibilities Evaluate and improve contract manufacturers processes through research design and collaboration. Develop and optimize manufacturing processes and equipment in partnership with vendors. Onboard and manage contract manufacturers ensuring regulatory compliance. Enhance More...

Job Description: The primary location for this role is Wilson NC. Design is taking place in Conshohocken PA. The design phase requires a hybrid work location of remote and onsite in Wilson as well as routine travel to Conshohocken. Once the design phase is completed this role will su More...

Responsibilities: However they will mainly fall within the areas of Pharmaceutical Biotechnology or Biologics Regulatory Affairs. This individual will prepare compile and submit CT/IND/MAA I NOA manage and implement label review translation requirements fee requirements and may suppo More...