Senior QC Specialist (d/f/m) / Višji specialist kontrole kakovosti (d/ž/m)

Job Description Summary

Job Description

As a (Senior) QC Specialist in the bioanalytical laboratory, you will play a key role in its establishment, the design of laboratory processes, and the implementation of analytical methods. This is an exceptional opportunity to actively contribute to laying the foundation for the successful operation of the laboratory.

Being a part of a dynamic and interdisciplinary team, you will gain valuable professional expertise and contribute to ensuring compliance with regulatory requirements and the high quality of bioanalytical tests that support commercial products.

Your key responsibilities:

Your responsibilities include, but not limited to:

• Active involvement in the handling of deviations (e.g. out-of-specification results – OOX) and leading and implementing corrective and preventive actions (CAPA).

• Support in the transfer of analytical methods: preparation of documentation, training of colleagues, and transfer of expert knowledge.

• Review and approval of analyses in accordance with GMP for analytical release purposes.

• Participation in internal and external inspections.

• Preparation and revision of documentation (Standard Operating Procedures – SOP, Work Instructions – WP, equipment qualification, and others).

• Good understanding of biological tests and the ELISA (Enzyme-Linked Immunosorbent Assay) method.

• Support to colleagues in daily tasks and resolving technical challenges.

• Active role in organizing and establishing an efficient bioanalytical laboratory.

What you will bring to the role:

• Completed at least Master’s level degree in a natural science field – biology, biochemistry, biotechnology, microbiology, laboratory biomedicine, or a related discipline.

• At least two years of experience in a GMP environment (for a senior position, at least five years of relevant experience). Candidates with experience in the pharmaceutical industry and in the quality control department are preferred. Knowledge and practical experience with cell culture work is desirable.

• Proficient in English (written and spoken).

• Computer literacy.

• High level of accuracy, responsibility, and ability to work in a team; well-developed communication skills; ability to make independent decisions and solve problems efficiently; adaptability, proactivity, and willingness to engage in continuous learning.

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Na delovnem mestu (senior) specialista za kontrolo kakovosti (QC) v bioanalitskem laboratoriju boste imeli ključno vlogo pri njegovi vzpostavitvi, oblikovanju laboratorijskih procesov ter implementaciji analitskih metod. Gre za izjemno priložnost, saj boste aktivno soustvarjali temelje za uspešno delovanje laboratorija.

Kot del dinamične in interdisciplinarne ekipe boste pridobili dragocena strokovna znanja ter prispevali k zagotavljanju skladnosti z regulatornimi zahtevami in visoki kakovosti bioanalitskih testov, ki podpirajo komercialne izdelke.

Vaše ključne odgovornosti:

• Aktivno sodelovanje pri obravnavi odstopanj (npr. rezultati izven specifikacij – OOX) ter vodenje in izvajanje korektivnih in preventivnih ukrepov (CAPA).
• Podpora pri prenosu analitskih metod: priprava dokumentacije, izobraževanje sodelavcev ter prenos strokovnega znanja.
• Pregled in odobritev analiz v skladu z GMP za namene analitskega sproščanja.
• Sodelovanje pri internih in zunanjih inšpekcijah.
• Priprava in revizija dokumentacije (standardni operativni postopki – SOP, delovna navodila – WP, kvalifikacija opreme in drugo).
• Dobro razumevanje bioloških testov in metode ELISA (Enzyme-Linked Immunosorbent Assay).
• Podpora sodelavcem pri vsakodnevnih nalogah in reševanju tehničnih izzivov.
• Aktivna vloga pri organizaciji in vzpostavitvi učinkovitega bioanalitskega laboratorija.

Vaš doprinos k delovnem mestu:

• Zaključena najmanj visokošolska 2. bolonjska stopnja naravoslovne smeri -  biologija, biokemija, biotehnologija, mikrobiologija, laboratorijska biomedicina ali sorodno področje.
• Najmanj dve leti izkušenj v GMP okolju (za višjo – senior pozicijo vsaj pet let relevantnih izkušenj). Prednost imajo kandidati z izkušnjami v farmaciji in v oddelku za in v oddelku za kontrolo kakovosti. Zaželeno znanje in praktične izkušnje z delom s celičnimi kulturami.
• Aktivno znanje angleškega jezika (pisno in ustno).
• Računalniška pismenost.
• Visoka stopnja natančnosti, odgovornosti in sposobnost timskega dela, dobro razvite komunikacijske veščine, sposobnost samostojnega odločanja in učinkovitega reševanja problemov, prilagodljivost, proaktivnost in pripravljenost na stalno učenje.

Global leader in generic and biosimilar medicines, operating as an independent company spun off from Novartis. Based in Basel.

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