QC Project Expert
Employer · EUROAPI
Chemist
Chemical engineer
Chemistry and physics technicianTemporaryTransportBudapest
As our new colleague, your task will be to participate in CDMO/CMO projects running in the Quality Control area as a delegated QC Expert, maintain contact with partners, prepare quotations for QC activities, plan resource requirements, professionally represent QC, and provide professional support for validation and transfer activities.
Tasks
- Performing and supporting QC analytical tasks related to CDMO and CMO projects
- Preparing and reviewing plans and protocols related to analytical method validations
- Preparing and reviewing protocols, reports, and related documentation for method transfers
- Regular review / planning the review of analytical methods
- Evaluating compliance with new regulatory requests, defining necessary tasks, and coordinating execution
- Performing pharmacopoeia tracking tasks, introducing them into local processes and documentation
- Providing information regarding analytical methods to the partner in connection with measurement outsourcing
- Initiating and expert review of change control procedures
- Maintaining and commissioning statistical records
- Preparing / commissioning risk assessments
- Creation, review, modification, querying, and maintenance of master data
- Preparing quality specifications, equipment operating instructions, tracking and documenting changes
- Executing processes related to instrument procurement and disposal
- Preparation and participation in inspections/audits
Conditions & benefits
Annual gross 636,000 Ft cafeteriaBased on company policy, even during the probationary period.Healthcare supportFree outpatient care and specialist examinations at the Budai Egészségközpont, as well as the opportunity for an annual preventive screening, for which we provide a paid day off.Sports opportunitiesDiscounted sports opportunities: AYCM membership, on-site fitness room and sauna, and discounted use of sports fields.InsurancesCollective life and accident insurance.Pension fundVoluntary pension fund membership with employer contribution.ParkingFree parking option.Travel allowanceTravel and weekend return travel expense reimbursement, uniform fixed travel allowance for our Budapest employees.BonusesAnnual bonus, referral bonus, and anniversary bonus.Parental leave14 weeks of paid parental leave for new parents.Language learningFree online language learning opportunity on the goFLUENT platform.Company eventsCommunity programs (such as family day, Mikulas and Christmas party).Coffee and snack cardWhich can be used in the site's vending machines.Other supportsDiverse one-off supports (glasses support, home-office equipment support).
Requirements
- Higher analytical degree (chemist / chemical engineer / bioengineer)
- min. 3-5 years of GMP pharmaceutical, analytical experience
- Preferably advanced, confident active English language skills both in writing and speaking
- Problem-solving, decision-making, and team-oriented skills
- Strong project management skills, ability to coordinate and implement multi-threaded QC project tasks
- Good communication skills
- Ability to work flexibly
- Minimum user-level computer skills (Word, Excel, Power Point)
- Knowledge of LIMS system is an advantage
- Knowledge of Empower system is an advantage