QA Engineer Support to QC
An exciting new opportunity arise to join our company as QA Engineer. In collaboration with QC teams, you guarantee the compliance of physico-chemistry, chemistry, biochemistry, microbiology activities supporting analytical of raw materials, intermediates of production and drug substances. You ensure the approval of validation documentation, stabilities studies, change controls, CAPA, assess and close out of deviations, identify recurrent deviations, contribute to risk analysis, ensure that QC operations are compliant with GLP/GMP, contribute to internal audits and HA inspections, to continuous projects improvement, collaborate with QC teams members, Production, E&M, other QU units and other sites.
Who you are :
· Bachelor or equivalent degree in chemistry/biotechnology/biology/biochemistry
· Minimum 5 years in QA/QC field experience in a Biotechnology company
· Knowledge of analytical methods qPCR, RP-HPLC, SE-HPLC, Elisa, CGE SDS, LAL, CFU, IEX, IR, NIR, Raman, TOC,….
· Knowledge of pharmacopeia’s Ph.Eur, USP, JP, ChP
· Knowledge of GLP, GMP, ICH
· Experience of GMP, Compliance
· Ability to interact with multidisciplinary teams
· Fluent English skills, Italian a plus.
Job Requisition ID: 205256
Career Level: D - Professional (4-9 years)
Working time model: full-time
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.
Job Segment: Biochemistry, Microbiology, Biotech, CAPA, QA, Science, Management, Quality