4 days ago

QA Operations Specialist Late Stage Clinical Projects

Glenmark Pharmaceuticals S.A.

  • Work region
  • Sector
  • Employment type
  • Position

Glenmark Pharmaceuticals (www.glenmarkpharma.com) is a global innovative pharmaceutical company with operations in more than 50 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development, primarily focused in the areas of oncology, respiratory disease and dermatology.


Glenmark’s biologics research operations in Switzerland focuses on the discovery and development of new biological entities from inception through preclinical and clinical studies. With a world-class, GMP-certified manufacturing line, our Swiss site located in the canton of Neuchâtel is well-positioned to fully serve the company’s growth in biologics research and development. The facility provides Glenmark with a complete suite of end-to-end, in-house capabilities necessary for early production of investigational biologics medicines, including cell line development, bioassay development and antibody engineering, as well as upstream and downstream development.


Glenmark is a rapidly growing company with many exciting and challenging career opportunities. We continue to recruit talented professionals who would like to contribute to our success and who share our values of respect, knowledge and achievement.

QA Operations Specialist Late Stage Clinical Projects

Glenmark Pharmaceuticals (www.glenmarkpharma.com) is a global innovative pharmaceutical company with operations in more than 50 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development, primarily focused in the areas of oncology, respiratory disease and dermatology.


Glenmark’s biologics research operations in Switzerland focuses on the discovery and development of new biological entities from inception through preclinical and clinical studies. With a world-class, GMP-certified manufacturing line, our Swiss site located in the canton of Neuchâtel is well-positioned to fully serve the company’s growth in biologics research and development. The facility provides Glenmark with a complete suite of end-to-end, in-house capabilities necessary for early production of investigational biologics medicines, including cell line development, bioassay development and antibody engineering, as well as upstream and downstream development.


Glenmark is a rapidly growing company with many exciting and challenging career opportunities. We continue to recruit talented professionals who would like to contribute to our success and who share our values of respect, knowledge and achievement.

RESPONSIBILITIES:


  • Coordinates and performs batch record disposition for manufactured products for late phase (Phase III and beyond) clinical trials.

  • Responsible for quality of marketed authorization readiness assessment and liaise with RA for strategy alignment.

  • Responsible for compliance review and approval of the following records: batch records/formulation records, release and stability data, method qualification/validation reports, stability protocols, product specification sheets, M/WCB records, IND/IMPD and development reports, etc.

  • Performs independent quality evaluation of investigational reports including root cause analysis cause/preventive action identification, CAPA effectiveness check and trending.

  • Reviews and approves deviations, CAPA’s, change controls, Quality Control LIR/OOS, Project VMP.

  • Participate in project teams to support GMP compliance for the projects.

  • Lead and assist in continuous improvement projects as assigned interacts with Team Leader, peers, internal customers, external clients and other cross functional peers to gain alignment on sound quality decisions.

  • Provide cGMP and associated OJT training to QA and other departments to improve right the first time (RTFT), high quality performance.

REQUIREMENTS:


  • Master’s degree or equivalent

  • Hands-on experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.

  • Knowledge of US, EU, PIC/s cGMP guidelines

  • Min. 3 years experience in Phase III and BLA requirements 

  • Manufacturing USP, DSP and/or Quality Control experience is a plus.

  • Experience with Quality Systems to include, Batch Record design/review and supporting investigations.

  • Good organization skills and attention to detail, with strong verbal and written communication skills.

  • Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a flexible and constructive manner.

  • Fluent English is required, French is highly desirable.

Chemin de la Combeta 5 2300 La Chaux-de-Fonds