QA Mana­ger (Drug Pro­duct Cli­ni­cal Manu­fac­tu­ring)

Vollzeit @Rand­stad (Schweiz) AG veröffentlicht 1 Tag ago

Job-Beschreibung

Job­de­scrip­ti­on

For one of our cli­ents, a glo­bal pio­neer in phar­maceu­ti­cals, we are curr­ent­ly loo­king for a QA Mana­ger — Drug Pro­duct Cli­ni­cal Manu­fac­tu­ring.

Gene­ral Infor­ma­ti­on:

  • Start Date: 01.02.2026
  • Latest Pos­si­ble Start Date: 01.03.2026
  • Plan­ned Employ­ment Dura­ti­on: 12 months con­tract with the pos­si­bi­li­ty of exten­si­on
  • Work­place: Basel
  • Workload: 100%
  • Home Office: pos­si­ble, 20%, on-site pre­sence requi­red
  • Team: 10 Peo­p­le
  • Depart­ment: IMP Qua­li­ty Ope­ra­ti­ons Basel & Kau (MMQEB)
  • Working Hours: Stan­dard

About the job:

The Syn­the­tic Mole­cu­les IMP Qua­li­ty Group is respon­si­ble for qua­li­ty over­sight of the Syn­the­tic Mole­cu­les Drug Sub­s­tance and Drug Pro­duct faci­li­ties, as well as the asso­cia­ted qua­li­ty con­trol. As an employee of the IMP Qua­li­ty Orga­ni­sa­ti­on Switz­er­land, you will ensu­re com­pli­ance with and con­ti­nuous impro­ve­ment of GMP com­pli­ance at the Drug Pro­duct IMP pro­duc­tion faci­li­ty in Basel.

The ide­al can­di­da­te:

Holds a Master’s degree in Natu­ral Sci­en­ces and has more than 10 years of pro­fes­sio­nal expe­ri­ence in the phar­maceu­ti­cal indus­try, inclu­ding at least 5 years in qua­li­ty assu­rance. The indi­vi­du­al has know­ledge of cGMP and qua­li­ty requi­re­ments for cli­ni­cal deve­lo­p­ment pha­ses, as well as a pro­ven track record of suc­cessful inspec­tions. Strong com­pu­ter skills and fluen­cy in Ger­man and Eng­lish com­ple­te the pro­fi­le.

Tasks & Respon­si­bi­li­ties:

  • Review of Drug Pro­duct Batch Records, in col­la­bo­ra­ti­on with the rele­vant depart­ments Con­duc­ting IMP Drug Pro­duct Release
  • Review and release of docu­ments such as: spe­ci­fi­ca­ti­ons, risk assess­ments, devia­ti­on reports, and chan­ge con­trol records.
  • Review and appr­oval of clea­ning pro­to­cols and reports
  • Sup­port of super­vi­sed depart­ments with GMP-rela­ted issues
  • Con­duc­ting self-inspec­tions

Must-haves:

  • Com­ple­ted degree in a natu­ral sci­ence, at least at Master’s level
  • At least 10 years of pro­fes­sio­nal expe­ri­ence in the phar­maceu­ti­cal indus­try, inclu­ding at least 5 years in qua­li­ty assu­rance
  • Know­ledge of cGMP and qua­li­ty requi­re­ments for cli­ni­cal deve­lo­p­ment pha­ses
  • Pro­ven suc­cess in inspec­tions by health aut­ho­ri­ties and inter­nal GMP audits
  • Good IT skills (MS Office) — espe­ci­al­ly expe­ri­ence with SAP and other qua­li­ty manage­ment sys­tems (e.g., Veeva Vault)
  • Flu­ent Ger­man and Eng­lish, both writ­ten and spo­ken.

Nice to have:

  • Pro­fes­sio­nal expe­ri­ence in phar­maceu­ti­cal deve­lo­p­ment (syn­the­tic mole­cu­les, drug pro­ducts).

Sounds inte­res­t­ing? App­ly Now! We look for­ward to recei­ving your appli­ca­ti­on.

Appli­ca­ti­on Sub­mis­si­on Dead­line: 12.01.2026

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