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Stellenangebote

Senior Specialist QA Operations

With you, for you!

You want to take on a new challenge? And could use professional support in finding your dream job? We at AssessA are specialized in assisting you on this path quickly, competently and free of charge.

Our client is looking for a

Specialist QA Engineer (m/f/d) 100%

to complement his team.

Form of employment: Temporary position for 18 months
Place of work: Neuchâtel region
Salary range: by agreement
Starting date: by agreement

Your tasks
  • Supports the deviation process. Ensure (and lead if necessary) that the initial quality assessment is completed in a timely manner according to requirements, support investigators and assess the criticality, review and approve the deviations and related CAPA.
  • Support the CAPA process by approving all the CAPA plan, and the completed action. Ensure review and approval of effectiveness check.
  • Supports the change control process. Performs action plan evaluation and coordinates change control progress within assigned areas of responsibility.
  • Reviews and approves as QA representative qualification and validation activities documents (protocols, reports…).
  • Perform batch record review and prepare batch release documentation on support of the Quality release team.
  • Contributes to risk assessments, e.g. related to quality issues or projects like new product introduction.
  • Represents QA within department and cross-functional project teams according to assignments.
  • Acts as backup for colleagues within QA Operations team.
  • Contributes to SOP/WP revision. Can take the ownership of processes and document revision
  • Supports health authorities and internal inspections in different
Your Qualifications
  • At least 5 years of experience in a pharmaceutical company or other related industry.
  • BS or MSc in Science or related field.
  • Good understanding of cGMPs and FDA regulatory requirements.
  • Good understanding of solid oral dosage form manufacturing processes is preferred
  • Proven interpersonal, collaborative and organizational skills. Ability to handle several tasks simultaneously.
  • Thorough understanding of cGMP requirements
  • Works independently on routine tasks, makes proposals and facilitate decision when escalation is needed.
  • Ability to focus attention to details and analytical thinking
  • Good written & oral communication skills.
  • Excellent Investigational and problem-solving skills.
  • Good Knowledge of most common office software (Microsoft Office).
  • French and English language mandatory
Our customer and we are looking forward to you!

For more information about this ad, I, Fabio Santoro, am at your disposal by phone at 076 566 40 42 or by e-mail welcome(a)assessa.ch!

Submit your application documents quickly and easily online or by e-mail now.

Art der Stelle: Vollzeit, Pensum: 90-100%, Pensum: 80-100%

Arbeitszeiten:

Tagschicht

Unser Kunde und wir freuen uns auf Sie!

Reichen Sie uns jetzt schnell und einfach Ihre Bewerbungsunterlagen online oder per E-Mail ein und erhalten Sie so bald als möglich eine Rückmeldung.

Art der Stelle: Vollzeit, Teilzeit, Pensum: 90-100%, Pensum: 80-100%, Festanstellung

Arbeitszeiten:
Montag bis Freitag

Für weitere Informationen zu diesem Inserat stehen wir Ihnen gerne telefonisch unter 076 566 40 42 oder per E-Mail welcome@assessa.ch zur Verfügung!

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