pqr quality specialist in Komárom Koppánymonostor

posted:
location
Komárom Koppánymonostor, Komárom-Esztergom
job type
Permanent
reference number
95775
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job description

Cégleírás / Organisation/Department

For our international pharmaceutical client we are currently looking for a PQR Quality Specialist colleague.

Pozíció leírása / Job description

- Prepares Product Quality Reviews for the EMEA region as per the relevant SOP.
- Primarily responsible for the preparation of oversight PQRs, this however, may be extended to other PQR types if necessary.
- Reviews, summarizes and generates a summary reports of product data.
- Liaises with both the company's sites and External (3 rd  party) manufacturers with the intent to gather relevant data.
- Produces a final report for review and approval, identifying any negative trends indicating concerns for product quality.
- Participates meetings related to the PQR process.
- Takes part in the creation, control and implementation of SOPs related to the function.

Elvárások / Requirements

 BSc/MSc degree (Chemical/Biological/Environmental Engineering)
- B2 level of English knowledge (mostly in written)
- Knowledge of GMP-guidelines
- Good communication and writing skills
- Thoroughness, high level of accuracy
- Independent decision-making ability
- User level of Microsoft Office knowledge

Amit kínálunk / Offer

The company offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement.

Kapcsolattartó / Applications

Nóra Csergő
nora.csergo@randstad.hu
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