Vor 15 Tagen veröffentlicht

CSV Senior Specialist

CSV Senior Specialist

CSV Senior Specialist

CSV Senior Specialist

Siegfried AG

Pharmazeutische Produkte, Arzneimittel

Malta

  • Art der Anstellung: Vollzeit
  • 53.500 € – 78.500 € (von XING geschätzt)
  • Vor Ort
  • Aktiv auf der Suche

CSV Senior Specialist

Über diesen Job

At its locations around the world, Siegfried offers employees exciting career opportunities in international settings. We cultivate multidisciplinary cooperation and encourage our staff to actively shape and influence their careers. This approach, coupled with our dynamic working environment, make Siegfried an attractive employer.

Your role

We are seeking a skilled CSV Senior Specialist to lead the validation of computerised systems across manufacturing, quality control, and warehouse operations. This critical role within the QA Validation team ensures compliance with regulatory standards and supports data integrity throughout the system lifecycle.

The chosen candidate will be responsible for:

  • Lead CSV projects, ensuring systems meet regulatory and data integrity standards from validation through to operational use.
  • Assess and manage changes to software and hardware, performing thorough risk analyses and ensuring validation lifecycle compliance.
  • Develop, execute, and maintain CSV protocols and documentation in line with FDA, EU GMP, and corporate standards.
  • Act as the CSV Subject Matter Expert during internal and external audits.
  • Support equipment qualification activities and coordinate with vendors for related periodic qualifications.
  • Contribute to quality investigations (e.g., deviations, CAPAs, complaints) in collaboration with the Quality Unit.

Your profile

· Graduate level qualification in a relevant field, preferably life sciences, combined with a strong IT background.

  • a regulated pharmaceutical or life sciences environment.

Working at Siegfried

Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by location-specific circumstances, legislation and customs.

Who we are

In the Midst of People’s Lives – Across the Globe The Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model. The Siegfried name stands for highest quality, efficiency, flexibility and safety. Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers’ value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production. We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products.

What we do in Hal Far

Hal Far is our drug product manufacturing site for solid dosage forms. It offers innovative and generic drug products for the global market with a competitive cost structure at Swiss quality level.

Main activities

  • GMP commercial manufacturing of solid oral pharmaceutical dosage forms
  • Supply of tablets, film tablets, and hard capsules filled with powder or pellets, in bulk or blister packed
  • cGMP high-potency suite

Features

  • 1 –10 μg / m³ segregated cGMP production areas for high-potency
  • 7 GMP suites: Dry & wet granulation, Tableting (up to 2 billion unit p.a.), Capsuling (up to 1 billion unit p.a.), Coating (up to 1 billion unit p.a.), Blistering (up to 100 million blisters p.a.)

Strategic importance

  • CMO for innovative and generic drug products for the global market
  • Competitive cost structure at Swiss quality level

Gehalts-Prognose

Unternehmens-Details

company logo

Siegfried AG

Pharmazeutische Produkte, Arzneimittel

1.001-5.000 Mitarbeitende

Zofingen, Schweiz

Wir benachrichtigen Dich gern über ähnliche Jobs in Malta:

Ähnliche Jobs

Referent Regulatory Affairs Bilanzkreismanagement (m/w/d)*

Quickborn

Schleswig-Holstein Netz GmbH

60.000 €79.000 €

Vor 19 Tagen veröffentlicht

Referent Regulatory Affairs Bilanzkreismanagement (m/w/d)*

Quickborn

Schleswig-Holstein Netz GmbH

60.000 €79.000 €

Vor 19 Tagen veröffentlicht

Externes Job-Angebot. Partner-Angebot

Koordinator*in (m/w/d) für seltende Erkrankungen

Mainz

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Vor 2 Tagen veröffentlicht

Externes Job-Angebot. Partner-Angebot

Koordinator*in (m/w/d) für seltende Erkrankungen

Mainz

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Vor 2 Tagen veröffentlicht

Externes Job-Angebot. Partner-Angebot

Diätologe (w/m/d)

Bad Gastein

Klinikum Bad Gastein

42.000 €47.000 €

Vor 2 Tagen veröffentlicht

Externes Job-Angebot. Partner-Angebot

Diätologe (w/m/d)

Bad Gastein

Klinikum Bad Gastein

42.000 €47.000 €

Vor 2 Tagen veröffentlicht

Health Economics & Market Access Specialist MedTech (German & English speaking) - Remote/Hybrid

Düsseldorf

Boston Scientific

73.000 €120.000 €

Vor 15 Tagen veröffentlicht

Health Economics & Market Access Specialist MedTech (German & English speaking) - Remote/Hybrid

Düsseldorf

Boston Scientific

73.000 €120.000 €

Vor 15 Tagen veröffentlicht

Externes Job-Angebot. Partner-Angebot

Referent Regulatory Affairs Bilanzkreismanagement (m/w/d)*

Quickborn

Schleswig-Holstein Netz GmbH

56.000 €74.000 €

Vor 7 Stunden veröffentlicht

Externes Job-Angebot. Partner-Angebot

Referent Regulatory Affairs Bilanzkreismanagement (m/w/d)*

Quickborn

Schleswig-Holstein Netz GmbH

56.000 €74.000 €

Vor 7 Stunden veröffentlicht

Externes Job-Angebot. Partner-Angebot

Referent:in (m/w/d) Innovation, HTA und Erstattungsbetrag

Bonn

Pharma Deutschland e.V.

58.000 €73.000 €

Vor 3 Tagen veröffentlicht

Externes Job-Angebot. Partner-Angebot

Referent:in (m/w/d) Innovation, HTA und Erstattungsbetrag

Bonn

Pharma Deutschland e.V.

58.000 €73.000 €

Vor 3 Tagen veröffentlicht

Externes Job-Angebot. Partner-Angebot

Referent:in (m/w/d) Innovation, HTA und Erstattungsbetrag

Berlin

Pharma Deutschland e.V.

59.000 €78.000 €

Vor 3 Tagen veröffentlicht

Externes Job-Angebot. Partner-Angebot

Referent:in (m/w/d) Innovation, HTA und Erstattungsbetrag

Berlin

Pharma Deutschland e.V.

59.000 €78.000 €

Vor 3 Tagen veröffentlicht

Externes Job-Angebot. Partner-Angebot

Manager/in Public Affairs mit Schwerpunkt Digitalisierung Gesundheit (w/m/d)

Frankfurt am Main

ZVEI e.V. – Verband der Elektro- und Digitalindustrie

57.000 €75.000 €

Vor 2 Tagen veröffentlicht

Externes Job-Angebot. Partner-Angebot

Manager/in Public Affairs mit Schwerpunkt Digitalisierung Gesundheit (w/m/d)

Frankfurt am Main

ZVEI e.V. – Verband der Elektro- und Digitalindustrie

57.000 €75.000 €

Vor 2 Tagen veröffentlicht

Health Economics & Market Access Manager Market Access Norderstedt Save Saved

Norderstedt

JOHNSON & JOHNSON

63.000 €92.000 €

Vor 20 Tagen veröffentlicht

Health Economics & Market Access Manager Market Access Norderstedt Save Saved

Norderstedt

JOHNSON & JOHNSON

63.000 €92.000 €

Vor 20 Tagen veröffentlicht