Site Head of Quality f/m

MERCK
Posted on

Type

Executive / senior industry position

This website uses 'cookies' to give you the best, most relevant experience. Using this website means you’re Ok with this. You can change which cookies are set at any time - and find out more about them in our cookie policy.

days alert frequency on certain daysShare this Job

 

 

As the Head of Quality, you will ensure the respect of Quality Systems & processes as required by current GMP. You will organize and supervise pharmaceutical operations and assure permanent compliance with the French Public Health code by delegation of the Responsible Pharmacist.

As a manager of the Quality Assurance and Quality Control departments you ensure the creation/update and monitoring of harmonized systems between departments.

You represent Semoy site in the relations with the authorities during inspections (Ansm, FDA, MHLW JP, Anvisa...), during audits (internal quality and external customers when acting as a CMO) and decline the Group Quality objectives in the site.

You also supervise and/or prepare annual assessments for applicants (Site Master File, Registration...).

With your team (approx 80p in total) you manage the analysis and treatment of Customer complaints, the implementation of annual validation plans and audits. You monitor regulatory aspects, guarantee the compliance of Drug Products according to Marketing Authorization Dossier, supervise the release or rejection of batches process and detect non-compliance risks by implementing preventive actions.

 

 

  • Work experience in pharmaceutical or chemical industry required
  • Pharmacist eductaion would be ideal
  • Demonstrated ability to manage multi-disciplinary teams in an international and matrix company
  • Strong experience in implementing and maintaining Quality excellence processes and operational actions in a production site(s)
  • Fluency in English is mandatory

Job Requisition ID:  197488 Working time model:  full-time

US Disclosure 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: Pharmaceutical, Public Health, QC, Quality, Science, Customer Service, Healthcare

Log on

We noticed that you are already a member of our Talent Community. Please enter your password to continue.

Log on

We noticed that you are already a member of our Talent Community. Please enter your password to continue.

Account Verification

We noticed you have accounts in our "Talent Community" and "Application" systems. We take security seriously and need to verify your identity to synchronise your accounts.

Account Verification

We noticed you have accounts in our "Talent Community" and "Application" systems. We take security seriously and need to verify your identity to synchronise your accounts.

  • Start Your Application

More Information

Posted on

Type

Executive / senior industry position

Darmstadt%2C%20Germany

Darmstadt , Germany