Specialist, QC Tech Transfer (Micro)

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Specialist, QC Tech Transfer (Micro)
Quality

The Specialist for Quality Control Tech Transfer is responsible to develop and validate Microbial test methods for new products transferred to the QC microbiological laboratory. This position supports writing/reviewing validation and verification documents and coordinate the necessary activities for new test methods coming into the laboratory. This person is also responsible for writing and reviewing deviations as needed and documenting all work according to cGMP and cGLP standards.

Key Responsibilities

  • Perform or provide guidance as subject matter expert on any of the following tests: Bioburden of API’s, water analysis, particle counting, microbial assay using HIAC and environmental monitoring
  • Develop and validate microbiological test methods for new pharmaceutical products transferred into the QC Microbiological laboratory
  • Work in cross functional teams to drive new product implementation and ensure laboratory readiness
  • Draft/review method validation protocols and reports
  • Overall management of the method validation and method transfer process for new products
  • Create Standard Operating Procedures (SOPs) and On Job Trainings (OJTs) for new products transferred into the laboratory
  • Identify and initiate laboratory investigations as needed
  • Support activities associated with investigations
  • Train laboratory personnel
  • Support routine testing and project tasks as required within the Microbiology Laboratory
  • Document all work performed according to applicable Current Good Documentation Practices
  • Recommend and initiate preventive and corrective action with regard to product non-conformances and quality system activities as they relate to the Microbiology laboratory activities
  • Support in review and approval laboratory test data
  • Support in review and approval of SOP’s and OJT’s test procedures of existing products, method/equipment validation protocols and reports
  • Communicate and coordinate inventory needs for test materials and supplies
  • Ensure the laboratory is kept in a safe working environment and in compliance with OSHA and other laboratory safety standards
  • Maintain a clean work environment with regards to cleaning schedules and good housekeeping standards
  • Perform additional tasks in relation to quality issues as agreed with the QC Management
  • Provide guidance on issue resolution based on the SOP and/or regulatory requirements
  • Manage and escalate Quality issues to the QC Management
  • Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in cGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality.
  • Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMPs, FDA, OSHA and other regulatory agencies.
  • Maintains knowledge of the latest guidelines of regulatory requirements of International Conference of Harmonization, compendia, USFDA and OSHA. Support the update of methods and instrument qualifications accordingly.
  • Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination

Qualifications

  • Bachelor’s degree of Science in Biology, Microbiology or related scientific discipline is required
  • Five (5) years of experience in a pharmaceutical environment within cGMP setting (Strongly Preferred); which may include the following: ICH Guidelines (Q2 R1), Compendial Testing, Equipment and Method Lifecycle Requirements, Media Fill Requirements, Quality Records (Trackwise) and project coordination.
  • Proven ability to demonstrate critical thinking, prioritize schedule, lead small projects, troubleshoot instrument issues, and work with well with peers in a team environment

Physical Requirements of the Role

Position is exposed to a number of environments, office, lab, outside, plant floor, etc. This role is: continuously sitting and typing. Frequently talking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 10 lbs. Standing, walking, bending over, and repetitive use of legs are done occasionally.

Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.

Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.
With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company’s evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Together you can help us lead the fight against infections.

Further information about Xellia can be found at: www.xellia.com
Connect with us on LinkedIn


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Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 22.11.2021, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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