Head Quality Control for Biologics (m/w/d).

Job ID: 10916

Jetzt bewerben
Discipline
Quality/Production
Type of employment
Festanstellung
Company

Our Client is a biopharma company with cutting-edge facilities. Operating across international centers specialized in clinical manufacturing and commercial scale production. Our client provides expertise and facilities from cell line development over process development, API production to fill & finish for partners and in-house biological pipeline. The leading full-service provider for biologics.

Responsibilities

Leads and management of Quality Control Departament, cooperation with internal and external customers. Motivating employees and support them in knowledge and technical expertise in techniques and analysis. Ensures the performance of all necessary biological tests and evaluation of related records. Ensures of performance appropriate transfers and validation. Ensures the maintenance and qualification of premises and equipment in QC Department. Ensures of providing introductory and tailored to the needs employee’s trainings. Selection and cooperation with contract laboratories. Participation and representation of Polpharma Biologics in internal and external audits. Keeping records and documentation in accordance with the applicable procedures and GMP rules.


- In detail:

  • Management of Quality Control Departament; motivating and oversight employees towards achieving the objectives set
  • Maintenence and development of Quality System in cooperation with Department of Technical Operations and alignment with Head of Quality Compliance and Quality Operations
  • Ensuring the performance of all necessary analysis and evaluation of records
  • Assurance that all investigations referring to deviations and compliants are performed properly, clarified (including root cause investigation) and closed, according to proper procedures and and law regulations
  • Ensuring of performance appropriate verifications of pharmacopeia’s methods
  • Ensuring the maintenance and qualification of premises and equipment in department
  • Ensuring of providing introductory and tailored to the needs employees trainings
  • Participation in internal and external audits
  • Ensures the compliance of the Quality Control with the internal quality system, GMP guidelines, EU, FDA and local regulations
  • Selection and cooperation with contract laboratories. Representing the company/Quality Control Department during regulatory inspections and audits
  • Planning own and subordinate employees work and progress reporting
Requirements
  • Higher education with a specialization in the fields: chemistry, biotechnology, molecular biology, biochemistry, pharmacy, medicine or related
  • Min. 5 years experience in regulated laboratory environment (preferred biotechnologic lab
  • Very good ability to organizing team's and own work, ability to work under time pressure
  • Practical and theoretical knowledge about transfer and validation of analytical methods, stability studies, biological methods e.g. ELISA, pharmacopoeal methods used for release intermediates and final drug product
  • Very good ability to cooperate with others in order to solve the problems
  • Broad knowledge of Quality Management Systems, in particular with regard to leading investigations of deviations and their evaluation, and corrective/preventive actions
  • Very good knowlegde of GMP, GLP and GDP principles and ability to introduce and supervise compliance
  • Fluent knowledge of English, both written and spoken
Region
Europa