Global GMP Quality Auditor (d/f/m), Kundl, Austria
Jobbeschreibung
Kundl, Tirol, Österreich
Sandoz
16.04.2024
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About the roleSandoz 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!Your key responsibilities: Your responsibilities include, but
are not limited to:• Support the strategic development of an effective
global risk-based audit strategy and program. Collect, collate and
incorporate input into the audit strategy and plan.• Plan, lead,
conduct, document and follow-up of GMP audit according to the
requirements specified in the respective Sandoz quality procedures as
well as applicable regulations, standards, quality agreements and
guidance documents.• For this role auditors will be given more complex
and higher-risk audits, such as sterile API, aseptic DP and
combination products. The ability to assess risk of these operations
is critical to success.• Provide technical guidance, mentoring and
training on audit activities as well as regulatory guidance for timely
remediation and recommendations regarding acceptability of the
proposed filing.• Prepare audit reports according to Sandoz
requirements and timelines.• Ensure appropriate escalation to
responsible management in case of critical findings and support
immediate follow-up measures according to Sandoz requirements on
management escalations and other relevant procedures. Ensure adequate
definition and recording of mitigation plans when applicable.• Assess
the adequacy of responses (CAPA plans) to audit findings in
cooperation with the stakeholder QA representative and auditee.• Act
as GMP compliance consultant for GMP trainings, task forces,
continuous improvement projects as needed. Assure permanent transfer
of best practice identified during the audit into Sandoz QMS system.•
Review and advise on relevant policies and procedures. Maintain
current knowledge of regulations, standards and guidance documents.•
Identify and report best practices and lessons learned to support
development/training of GMP auditors.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: •
Degree in Chemistry, Pharmacy, Biology, Engineering or another related
science (advanced degree preferred)• Excellent oral and written
English communication skills plus good knowledge/mother tongue of an
additional language (e.g. German, French, Italian, Chinese or
Spanish)• At least 10 years broad experience in pharmaceutical or
medical device industry, where the operational experience should
include QA/QC management and manufacturing, development or other
relevant experience e.g. working at a regulatory health authority.• 3
years auditing experience preferred and excellent knowledge of
regulatory requirements.• Willingness to travel approximately 60% of
the time• Expertise in at least one of the following areas: DP
Manufacturing, Laboratories activities, Medical Devices, API,
Excipients, Sterile, Biologics, Microbiology, Computer System
Validation, Packaging activities, Quality Systems.• Experience and/or
interaction with local Health Authority and sporadically with other
Health Authorities.• Strong interpersonal skills, including diplomacy
and persuasion, used in obtaining cooperation and consensus with
Novartis colleagues, vendors and customers.• Sound and practical
judgement in the interpretation and application of regulations and
standards• Ability to independently manage and objectively evaluate
complex compliance issues with minimal supervision.• Excellent
leadership and facilitation skillsPlease note, that this position is
based in Austria, therefore living in Austria is an advantage!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). The actual salary will be significantly higher, as
we strive to maintain a competitive position in the market and
consider your previous experience, qualifications and individual
competencies. 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