cGxPServe

Responsibilities: Duration: 12 months contract extendable up to 36 months. The Client team is seeking a Regulatory Affairs Specialist to contribute to the development and of effective regulatory strategies for investigational products. The successful candidate will serve as a regula More...

Responsibilities: Provide quality oversight for commissioning qualification and validation of manufacturing and lab systems. Review and support investigations for deviations related to equipment utilities automation and lab instruments. Review/approve change controls and risk assess More...

Responsibilities: The SAS/Statistical Programmer will be responsible for providing programming support for clinical trials conducted within the pharmaceutical industry. The successful candidate will work closely with the Biostatisticians Data Managers and Clinical Research teams to d More...

Overview: Manufacturing Engineer will interact with Opco partner and get necessary information to perform the task and deliver output. He / She should interpret the product process requirement and create work instruction for weld shop / assembly of production lines. He / She should More...

Responsibilities: Develop test and validate SAS programs to generate analysis datasets (ADaM) TLFs and adhoc reports. Ensure datasets and outputs adhere to CDISC standards and regulatory guidelines (e.g. FDA EMA). Collaborate with Biostatisticians Data Management and Clinical Teams More...

Responsibilities: Lead the validation team in a strategic riskbased approach that optimizes legacy Computer System documentation CSA strategies and strong SAP ECC>S/4 HANAconversion knowledge to successfully deliver a validated system meeting all project requirements. Review approva More...

Responsibilities: Research & Monitoring Proficiency. Ability to synthesize large volumes of information into concise actionable insights. Ability to create reports and alerts for crossfunctional teams. The Sr Associate Regulatory Intelligence role performs monitoring and analysis of More...

Responsibilities: Main responsibility includes design of Case Report Forms development of edit check specifications creation of test scripts and testing of study database query processing data reporting putting in place data management plans timelines and manage multiple projects th More...

Job Description: The Analyst Field Planning & Analytics is a role which will aid in data analytics and process reporting to help drive initiatives and strategy for Field Programming. The Analyst will work collaboratively with our field and marketing colleagues as well as home office More...

Job description: Our client is seeking a Temporary Attorney to join our legal team in support of our Cell & Gene Technologies (CGT) platform. This role provides general legal counsel with a focus on complex commercial agreements compliance and daytoday operational matters for a dynam More...

Responsibilities: Strong knowledge of PIMS (Process Information Management Systems) preferrable Aspen IP.21. Experience integrating PIMS systems with various other OT systems (ex. Automation/Controls systems). Experience with OPC communication and SQL is preferred. Support the imple More...

Job Description: The Data Entry Specialists primary responsibility is transcribing data into Global Data Mart (GDM). The DE Specialist will support the MSAT Team the Process Analytics Team the Process Validation Team and Investigation teams thereby supporting the critical successive More...

Roles & Responsibilities: 10 years Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems Product Serialization systems MES systems. Perform review for GxP systems to ensure compliance with regulatory requirements Working knowl More...

Responsibilities: This role is designed for a specialist who is passionate about regulatory affairs compliance and the energy sector. As a Consulting Regulatory Specialist you will be responsible for managing and ensuring compliance with all regulatory requirements guidelines and pro More...

Responsibilities: Provide quality deliverables by following corporate and departmental policies procedures and applicable standards. Perform data manipulation analysis and reporting of clinical trial data. Create analysis files tables listings and figures and validation of those file More...

Responsibilities: The Regulatory Affairs CMC Senior Manager at is responsible for providing strategic direction tactical support and technical expertise for CMC regulatory activities and related regulatory initiatives. Responsible for guiding and overseeing the preparation of complex More...

Roles and responsibilities: Experience in Pharma or Med device. Previous experience as a CQV Engineer in the Pharmaceutical or Med Device production environment to include. Performing Risk Assessments by assessing machinery for potential failure modes/quality issues and then writing More...

Roles & Responsibilities: Bachelors degree in science related field. Minimum of 9 years pharmaceutical industry data management experience. Working knowledge of Good Clinical Practices Good Manufacturing Practices Clinical research Clinical trial process and related regulatory requir More...

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

Responsibilities: Our client is searching for a Quality Engineer to support various activities for their specimen management instruments. This role is critical in ensuring the ongoing quality and compliance of supplierprovided components and materials. The ideal candidate will More...