QA Manager (d/f/m) ESO
Jobbeschreibung
Kundl, Tirol, Österreich
Sandoz
16.04.2024
Möchten Sie Updates für diesen und ähnliche Jobs?
About the roleQA Manager (d/f/m) ESO, Kundl, Tyrol, Austria Sandoz is
going through an exciting and transformative period as a global leader
and pioneering provider of sustainable Generic and Biosimilar
medicines.Now as an independently listed company, Sandoz aims to
increase its strategic focus, operate with greater agility, set
clearer business objectives, enhance shareholder returns, and
strengthen its culture for us, the Sandoz associates. This is an
exciting time in our history, and by creating a new and ambitious
path, it will provide a unique opportunity for us all, both
professionally and personally.Join us as a Founder of our ‘new’
Sandoz!This position ensures all aspects of manufacturing, testing,
release and distribution for bio-logics and/or sterile pharmaceutical
products at external supplier sites comply with international
standards of current Good Manufacturing Practice (cGMP), regulatory
requirements, the Sandoz Quality Manual, and the applicable Quality
Agreements.Your key responsibilities: Your responsibilities include,
but are not limited to:• Acts as Single Point of Contact / SPOC for
all quality related activities at assigned external suppliers. •
Supplier qualification: Ensures a valid Quality Agreement in line with
the requirements of the Sandoz global template is in place and
continuously amended to the business needs.• Routine monitoring:
Assesses quality trends and drives continuous improvement including
stability reports and annual product quality reviews. • Incident
management: Manages all quality issues (complaints, deviations, OOX).
• Change controls: Ensures that change requests, either from the
external supplier or from Sandoz, are managed appropriately from
receipt, through to the implementation and closure.• Manufacturing
process and analytical methods transfers: Ensures QA Oversight during
commercial product transfers.Commitment to Diversity & Inclusion:We
are committed to building an outstanding, inclusive work environment
and diverse teams representative of the patients and communities we
serve.Role RequirementsWhat you’ll bring to the role: Essential: •
Bachelor or higher in Biochemistry, Chemistry, Microbiology or
anoth-er related science• Fluent in speaking / writing in English• Min
5 years of experience in in the pharmaceutical industry. Min 3 years
of experience in the manufacturing of sterile pharmaceuticals. Basic
knowledge in aseptic/sterile pharmaceutical processes and
manufacturing of biologics.• Min 3 years of experience in operational
quality assurance. Advanced knowledge of cGMP requirements for major
regulated markets (EU, US). Basic experience with FDA, EMEA and other
Health Authorities. Advanced understanding of risk management. Basic
understanding of project management.• Advanced communication and basic
negations skills. Basic decision-making ability skills.Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global
medicines industry. Sandoz, a leader in this sector, touched the lives
of almost 500 million patients last year and while we are proud of
this achievement, we have an ambition to do more!With investments in
new development capabilities, state-of-the-art production sites, new
acquisitions, and partnerships, we have the opportunity to shape the
future of Sandoz and help more patients gain access to low-cost,
high-quality medicines, sustainably.Our momentum and entrepreneurial
spirit is powered by an open, collaborative culture driven by our
talented and ambitious colleagues, who, in return for applying their
skills experience an agile and collegiate environment with impactful,
flexible-hybrid careers, where diversity is welcomed and where
personal growth is encouraged!The future is ours to shape! Imagine
what you could do here at Sandoz! In addition to a market-competitive
base salary, we offer an attractive incentive program, a modern
company pension scheme, childcare facilities, learning and development
options as well as worldwide career opportunities. In accordance with
Austrian law, we are obliged to disclose the minimum salary as stated
in the collective bargaining agreement. For this position the minimum
salary is 60,212.18/year (on a full time basis). In most cases, the
actual salary will be higher, as we strive to maintain a competitive
position in the market and consider your previous experience,
qualifications and individual competencies. We are open for part-time
and job sharing models and support flexible and remote working where
possible. Join our Sandoz Network: If this role is not suitable to
your experience or career goals but you wish to stay connected to hear
more about Sandoz and our career opportunities, join the Network here:
Business UnitNON-NVS TSA QUALITY STO Work LocationKundl Company/Legal
EntitySandoz GmbHFunctional AreaQuality Job TypeFull TimeEmployment
TypeRegular Shift WorkNoEarly TalentNoCountry: Austria