Summary
The specialist, QA analytical will be responsible for supporting the QA Operations department for overseeing analytical activities performed at Incyte contracted laboratories.
The position will cover commercial Incyte Drug Substances and Drug Product.
Duties and Responsibilities
Manage the day-to day quality oversight of International contract labs, including compliance and performance monitoring
Review and approve analytical methods validation protocols and reports
Review and approve analytical methods and specifications
Review and approve stability protocols and reports
Perform analytical raw data and COA review
Generate Incyte COAs supporting disposition of Incyte products.
Coordinate resolution of analytical deviations, OOS and OOT
Ensure and monitor implementation of analytical changes at contract labs
Ensure and monitor implementation of CAPA at contract labs,
Perform analytical data trending and statistical analysis
Coordinate the collect of APQR data and author analytical part of Incyte APQR
Contribute to the maintenance of Incyte Quality System,
Maintain Incytes Quality analytical SOPs
Act as back-up of other Incyte Biosciences International QA Operations Managers
Support the QA operations department for Manufacturing Batch Record Reviews activities,
Perform external and internal audits according to Incyte audit program,
Support the CMC group by reviewing the associated analytical sections prior to regulatory submission.
Interpret GMP, general regulatory requirements and Quality systems regulations in the area of Quality control and ensure implementation as applicable,
Performs all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements,
Stay current with the applicable regulations and promote Quality across the Incyte organization
Company Culture
Contribute positively to a strong culture of business integrity and ethics,
Act within compliance and legal requirements as well as within company guidelines
Requirements
Academic degree in Chemistry or Pharmacy,
Experience of min 5 years in Pharmaceutical or Biopharmaceutical industry with at least 3 or more years of QC experience at a manufacturing site
Good understanding of analytical method validation, pharmaceutical drug substance/drug product analytical technique and microbiological testing requirements. Direct experience laboratory equipment/testing and software preferred (e.g. UV, IR, MS, NMR, XRPD, HPLC, GC)
Experience in dealing with Contractors,
Thorough knowledge in cGMP and global regulatory requirements,
Demonstrated ability to write technical documents such as PQR
Qualified auditor,
Strong Interpersonal skills,
Strong verbal and written communication skills with well-structured communication,
English fluency written and spoken (the company language), German and French are an asset,
Travel up to 20%,
Results focused with good interpersonal skills, diplomacy, negotiation skills and common sense