QA Operations Expert (m/f/d) - 50%

at  Novartis

ESSENTIAL REQUIREMENTS:

• University Degree in Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent.
• Professional experience in Pharmaceutical industry, Biopharmaceutical or API products.
• Excellent working knowledge and experience of pharmaceutical QA and cGMP standards.
• Proof of qualification and nomination as Control Laboratory Manager, Kontrollaborleiter/in (KLL), according to Regulation on Operating Instructions for Medicinal Products (AMBO).
• English proficiency.

DESIRED REQUIREMENTS:

• German knowledge.

ADJUSTMENTS FOR APPLICANTS WITH DISABILITIES:

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

ABOUT THE ROLE

Location: Austria, Tyrol, Schaftenau #LI-Hybrid
We We are seeking a QA Operations Expert (m/f/d) to help us with the implementation of quality assurance tasks such us release process of compounding / filling / inspection / packaging products and further development of the existing quality system.
This role will work directly with the QA Operations Team and reports to the QA Operations Team Leader.

KEY RESPONSIBILITIES:

• Ensuring GMP Compliance in Production.
• Participation in the preparation and approval of validations (e.g. process, mediafills, smoke studies), transfers and SOPs
• Approval of specifications, sampling instructions, test methods and other quality control procedures; as well as participation in and evaluation of changes in the process and specifications.
• Ensuring the evaluation of batch production and testing protocols.
• Timely decision on the use of intermediate and bulk products.
• Control and oversight of aseptic processes.
• Assisting in the preparation of QA agreements and answers to health authority questions, as well as preparation and participation in audits and inspections.
• Performance and approval of investigations of deviations and Out Of Specifications and Expectations (OOS and OOE), and support in complaint investigation, together with the evaluation and approval of CAPA measures and risk assessments.
• Alignment and improvement of existing processes and procedures to establish the Drug Production Schaftenau quality system.