Quality Responsible - Qualification & Validation

Nivel cariera

Entry (0-2 ani), Middle (2-5 ani)

Limbi vorbite

engleză

Adresa/ adresele jobului

Timișoara


Responsibilities:

  • Create, update and ensure traceability of all Qualification, Validation activities and all related Risk assessments, Deviation, Corrective actions and Change control activities
  • Ensure that internal and external partners (within the assigned teams) use the correct documentation (. URS Template - User Requirements Specification) 
  • Prepare the qualification documentation for equipment and update it when necessary
  • Prepare the validation documentation for processes and update it when necessary
  • Follow, check, centralize all data obtained during the equipment qualification and processes validation
  • Ensure that all test are documented with evidence following the GMP (Good Manufacturing Practice) good documentation practices
  • Create risk analysis for equipment and processes and prepare the documentation
  • Follow, check, centralize all deviations and corrective actions occurred during the equipment qualification and processes validation
  • Ensure that all deviations occurred are finalized / closed before the finalization of qualifications / validations
  • Ensure that all corrective actions occurred are finalized / closed before the finalization of qualifications / validations
  • Initiate and coordinate the Change control process occurred during qualifications and validations
  • Plan the test activities in term of time and personnel
  • Coordinate and assist the execution of activities / tests for equipment qualification and process validation
  • Supervise the qualification / validation activities conducted by third party / vendors
  • Attend all trainings organized by B. Braun (locally or globally)

Requirements:

  • University degree in: Pharmacy, Medicine, Chemistry, Biology or equivalent
  • Experience: preferably at least 1 year into a similar position
  • Thorough knowledge on specific activities of qualification and validation regarding equipment / processes of pharmaceutical industry – is an advantage
  • General knowledge of GMP (Good Manufacturing Practice). Thorough knowledge of GMP – is an advantage
  • Preferably: trainings for qualification / validation activities, knowledge of GAMP (Good Automated Manufacturing Practice)
  • Availability for frequent traveling abroad on longer term (weeks- months)
  • Ability to understand quality principles
  • Ability to bring documented arguments for having an opinion
  • Ability to assimilate and follow a solution chosen by the management
  • Ability to focus on solutions
  • Advanced knowledge on English and operating the PC
  • Ability to discuss in a civilized, open and focused on solutions way, without taking the discussed aspects personally and without bringing personal accusations
  • Ability to integrate into a team

We offer:

For start, 6 months fix-term contract and, after activity evaluation, unlimited contract.

Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. We can offer you interesting, varied tasks and excellent opportunities for advancement.