QA Operations Specialist - 1 year mission

Kelly Services — Suisse romande
13.02.2020 | Employee | 100%


Kelly Scientific is looking for its pharmaceutical partner localized in Switzerland a QA Operations Specialist - 1 year mission.

QA Operations Specialist - 1 year mission

RESPONSABILITIES

  • ...

QA Operations Specialist - 1 year mission


Kelly Scientific is looking for its pharmaceutical partner localized in Switzerland a QA Operations Specialist - 1 year mission.

QA Operations Specialist - 1 year mission

RESPONSABILITIES

  • Supports the design of Master Batch Records for bulk or packaged commercial drug products.
  • Responsible for the review "on the floor' of executed batch records and associated QA samples.
  • Handles deviations, CAPA, Change Control and to ensure the execution and the follow up of escalation processes.
  • Handles in cooperation with partners for GMP activities.
  • Writes new, revises and makes recommendations for SOP and quality documents for Quality
  • department and supported departments of manufacturing site.
  • Handles qualification and validation documentation for QA review of relevant documents / reports (DQ, IQ, OQ, PQ, Cleaning and Process Validation) and supports execution.
  • Supports in cooperation with Corporate Quality the approval and qualification of suppliers of bulk drug products, quality control laboratories, packaging services and packaging materials including participation to auditing and establishing Technical/Quality Agreements.
  • Supports the approval of GMP Material suppliers for production site and ensures periodic evaluation of GMP Material Suppliers as required in collaboration with GMP/GDP audit function.
  • Supports the internal GMP-audits process including the yearly internal audit plans, the writing of audits reports (paper or electronically) and the follow up and the implementation of the internal audit CAPAs.
  • Ensures successful Authorities inspections by participating in the preparation and the support in different roles.
  • Support QC/QA transfers of new products/methods.
  • Ensures that all regulations concerning product security and all established working methods are respected within the area of responsibility.
  • Working hours: Shift 2x8
PROFILE
  • At least 2 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical
  • company or other related industry.
  • BSc/BA or MSc in Science or relevant discipline.
  • Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
  • Good understanding of solid oral dosage form packaging and warehousing, or bulk and QC
  • processes.
  • Excellent interpersonal collaborative, organizational and training skills.
  • Works independently, yet effectively in a team environment, makes proposals and facilitate decision when escalation is needed.
  • Excellent written & oral communication skills in both French and English.
  • Excellent investigational skills and QA problem solving skills.
  • Ability to focus attention to details.
  • Collaborative, organizational
  • Sense of responsibility, reliability, team spirit, initiative and service.
  • Knowledge of most common office software.
YOUR KELLY CONTACT
Mrs Charline Maire
Consultant Professional Staffing Life Science
Kelly Scientific Geneva
 

13.02.2020
Employee, 100%

Contact

Kelly Services

Charline Maire

Rue du Rhône 114

1204 Genève

Phone: +41227371207

Fax: +41227371213


Kelly Scientific Resources

rue du Rhône 114Geneve

Industry

Human resources / Personnel services

Kelly Scientific Resources

rue du Rhône 114Geneve

Industry

Human resources / Personnel services
Salary

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