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**Your Key Responsibilities**:
Your responsibilities include, but not limited to:

- Lead External Suppliers **Qualification **process. Acts as **Single Point of Contact / SPOC **for all quality related activities at the External Supplier. Ensure that all aspects of the anaging, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in **compliance **with the Sandoz Pharma Quality Manual, the effective Quality Agreement that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs.
- **Responsible for driving / initiating External Supplier Quality Risk assessments **to be carried out for all External Suppliers. Gaps are Quality Systems to be identified with an evaluation of the associated risks. Remediation plans are to be defined and execution is to be monitored to ensure that issues are suitably addressed
- Provide the quality presence and in-put to **Technical meetings **with the External suppliers and establish good working relationships with clear communication and defined actions and goals. Ensure that a valid **QA agreement **defined in line with the requirements of the Global template is in place which clearly defines cGMP roles and responsibilities between Sandoz and the External Supplier, as well as Product details and requirements.
- Request, review and process GMP documentation as defined by the Quality Agreement and Sandoz SOPs. **Handle the quality aspects **of the relationship in accordance with the effective Quality Agreement. Perform the required periodic review and make recommendations for amendments to the agreement based on identified needs and issues.
- Responsible for coordinating and ensuring that Quality **auditing **of External suppliers is carried out according to the Sandoz Quality Manual - maintain an annual auditing program, participate in and/or lead audits, handle action plans and follow up on agreed upon CAPAs. Ensure site readiness for regulatory inspections at External suppliers where appropriate.
- Handle **critical quality issues **(deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc) according to the Quality Agreement and the Sandoz Quality Manual. Ensure investigations are correctly implemented. **Raise **any issues or instances of instability per the Sandoz partner concern policy, and initiate any market action that is required. Support / participate in Sandoz Emergency Management cases as required.
- Ensure that **Change requests, **either from the External Supplier or from Sandoz, are handled according to the Quality Agreement and Sandoz SOPs from receipt, through to the implementation and closure. Responsible for assessing **quality trends **and driving **continuous improvement **for processes and product quality performance.
- **Stability reports and PQR’s, **Ensure that the External Supplier provides the required product review or the data as specified in the relevant Quality Agreement on an annual basis. Critically assess the performance of the product and process and provide the assessment to the report annually. Performing technical visits of suppliers, issue technical visit reports and perform follow-up.

**What you’ll bring to the role**:
**Essential Requirements**:
**Education**: Bachelor or higher degree; preferred in Biochemistry, Chemistry, Microbiology or another related science

**Languages**:Fluent in speaking / writing in English

**Experience**:

- 10 to 15 years experience in the pharmaceutical industry, with direct experience with Pharmaceutical/Biopharmaceutical/API products. Experience in QA Operations, production, QC and/or other relevant operational areas, but must include mínimally 5 years in QA, and 3 years of management and or project management experience.
- Thorough knowledge of cGMP requirements
- Strong understanding of regulatory requirements for commercial products
- Proven track record with FDA, EMEA and other Health Authorities.
- Strong understanding of risk assessment and risk management fundamentals/tools
- Strong Technical understanding of pharmaceutical processes
- Team and consensus builder, with definitive and authoritative decision making ability

**You’ll receive**:
Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.

**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.

The future is ours to shape

Sandoz

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