QA Operations Expert

vor 3 Wochen

Langkampfen T, Österreich Novartis Vollzeit

392415BR

**QA Operations Expert (M/F/d)**:
Austria

**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.

**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 Requirements**

**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 & German proficiency.

**Why Novartis?**

**You’ll receive**:
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. 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 € 60.212,18year (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.
**Adjustments for Applicants with Disabilities**:
**Join our Novartis Network**:
**Division**

Operations

**Business Unit**

QUALITY

**Work Location**

Schaftenau

**Company/Legal Entity**

NVS Pharmaceutical Manu. GmbH

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

Yes

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