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Job Details

Quality Assurance Manager - External Supply Operations

Company: Novartis
Location: Ireland Ringaskiddy County Cork
Reference: 211177BR
Closing Date: 21 Sep 17
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

Quality Assurance Manager - External Supply Operations, Novartis, Ringaskiddy, Ireland Job Summary: Do you want to work for a Global Pharmaceutical company where you will get recognized for your hard work and commitment? Look no further, apply today. Quality Assurance Manager. ...

Requirements:

Quality Assurance Manager - External Supply Operations, Novartis, Ringaskiddy, Ireland

Job Summary:

Do you want to work for a Global Pharmaceutical company where you will get recognized for your hard work and commitment? Look no further, apply today. Quality Assurance Manager.

Job purpose:

Approve and maintain quality oversight with respect to supply of materials to Novartis, from global external suppliers of chemicals (strategic raw materials, Intermediates and Drug Substances) by working in Supply Relationship Teams.

These materials are being supplied to >75 Novartis Technical Operation sites. To ensure appropriate quality oversight, assessment and mitigation of quality risks that may potentially negatively impact the supply of purchased strategic ESO chemicals (regulatory starting materials, Intermediates and API’s), and to ensure that all aspects of the relationship and management thereof, are in compliance with cGMP’s, regulatory requirements, the Novartis Quality Manual and Pharma industry practices.

Key Responsibilities:

• Responsible for ensuring quality oversight for purchased API’s and strategically important regulatory starting materials and chemical intermediates supplied into Novartis NTO sites worldwide.
• Manage and maintain the approval, qualification and certification status for all external Suppliers and maintain all associated quality systems.
• Manage escalation of all potential quality issues as per the Novartis escalation policy and to higher level management, especially to the ESO Global QA Head Chemicals & Anti-infectives, and initiating all actions as defined. (483’s, Warning Letters, FDA Field Alert Reports, Notifications to the Drug Shortage Office etc).
• Manage major and critical quality issues (Complaints, deviations, recalls, counterfeits, product tampering, stability failures and any regulatory non-compliance identified, as applicable) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed and all appropriate Corrective and Preventative actions are put in place in a timely manner.
• Lead External Suppliers Qualification process. Maintain and update documents related to the supplier qualification and monitoring.
• Provide direction and support to third parties and ensure that they are qualified, achieve a high level of competence and are motivated to carry out their duties to ensure that the Chemicals produced meet the Novartis quality, efficacy and safety requirements.
.• Support remediation of any gaps identified in Quality Systems and ensure any issues are addressed.

About Novartis:

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. Novartis products are available in more than 180 countries around the world. For more information, please visit www.novartis.com

One of the first pharmaceutical companies to locate in Ireland in the 1950’s, Novartis has strong history of investing in Ireland over the last sixty years.
Novartis employs approximately over 1,600 people across 3 locations in Cork and Dublin. Novartis manufacturing and development is based in Ringaskiddy, Co Cork. Alcon, also located in Cork, is the leading manufacturer of eye care technologies. In 2013 Novartis established a Global Business Services Center in Elm Park, Dublin 4. The country pharmaceutical organisation (CPO), Novartis Pharmaceuticals, is also based in Elm Park, Dublin 4.

#LI-NOV Minimum requirements Requirements:

• Bachelor or higher in Biochemistry, Chemistry or another related science
• Several years experience in the pharmaceutical industry, with direct experience with APIs.
• Experience in QA Operations, production, QC and/or other relevant operational areas. Fluent in speaking / writing in English

Apply for this job: Quality Assurance Manager - External Supply Operations

Contact Information:

Address:  Novartis Pharmaceuticals UK Limited
Frimley Business Park
Camberley
Surrey
GU16 7SR
England
Tel:  +44 (0)1276 692255
Fax:  +44 (0)1276 692508
Website:  Visit Our Web Site

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