2 Gmp Audit Jobs

Contribute to establishing the strategic direction 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 Novartis Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents. For this expert role, the leader in this position is able to audit complex and high-risk sites and activities. The leader in this position is considered an expert and SME in one or more manufacturing areas, such as sterile manufacturing, combination products, biologics, etc. Provide technical guidance, mentoring, and training on audit activities. Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing. Prepare audit reports according to NVS requirements and timelines. Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to NVS 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. Review and advise on relevant policies and procedures. Mentor junior GMP staff as required. Ability to perform training for non-certified and junior GMP staff. Maintain current, expert knowledge of regulations and elaborate best practices auditing guideline (when applicable). Support development/training of GMP auditors. Support HA commitments and global commitments/initiatives as an outcome of inspection findings. Essential Requirements: At least 15 years broad experience in Pharmaceutical or Medical Device Industry. The operational experience should include QA/QC management and manufacturing, or development or other relevant experience e.g. working at a regulatory health authority. At least 3+ years auditing experience, 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. Excellent interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with Novartis colleagues, vendors and customers. The Associate must be able to effectively represent the department both internally and externally. 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 skills Desirable Requirements: Degree in Chemistry, Pharmacy, Biology, Engineering or another related science Excellent oral and written English communication skills. Preferable: Good knowledge/mother tongue of an additional language (e.g. German, French, Italian, Chinese, or Spanish) is preferred.

At McCormick, we bring our passion for flavor to work each day. We encourage growth, respect everyone's contributions and do what's right for our business, our people, our communities and our planet. Join us on our quest to make every meal and moment better. Founded in Baltimore, MD in 1889 in a room and a cellar by 25-year-old Willoughby McCormick with three employees, McCormick is a global leader in flavor. With over 14,000 employees around the world and more than $6 Billion in annual sales, the Company manufactures, markets, and distributes spices, seasoning mixes, condiments and other flavorful products to the entire food industry, retail outlets, food manufacturers, food service businesses and consumers. While our global headquarters are in the Baltimore, Maryland, USA area, McCormick operates and serves customers from nearly 60 locations in 25 countries and 170 markets in Asia-Pacific, China, Europe, Middle East and Africa, and the Americas, including North, South and Central America with recognized brands. At McCormick, we have over a 100-year legacy based on our Power of People principle. This principle fosters an unusually dedicated workforce requiring a culture of respect, recognition, inclusion and collaboration based on the highest ethical values. Position Overview: Managing, assessing and processing Suppliers approval information. Reviewing/assessing the Approval form and consulting others as required including external parties. Ensuring Vendor Assurance reviews are completed on plan and in accordance with McCormick review standards and external certification requirements. Assessing compliance and safety of raw material/ packaging and working with Category Specialists to determine whether supplier specifications are compliant with McCormick standards; ensuring suppliers close gaps where non-compliance exists. Coordinating Non-Conformance process and Corrective and Preventive Actions with the Supplier and liaising with internal stakeholders as appropriate. Responsible for maintaining audit trail and communications during Non-Conformance processes. Regular communication with Category Specialists and Supplier Quality Managers to ensure team focus is aligned to business requirement. Providing data to category specialists to enable them to produce regular reports of key KPI. Individual contributor reporting to Manager QA and Supplier Quality. Rotating Shift. Key Responsibilities: Supplier Management - Supplier qualification, Arranging Raw Material documents and approval, Vendor performance. Vendor risk assessments, raw material risk assessments, management of RM/PM specification after approval. Interact with suppliers at any and all levels required to establish and maintain effective business relationships. Management of supplier issues and CAPA. Participate or lead the development of new or revised QA procedures as assigned by the Global Quality and Regulatory. Uploading of procedure, GMP audit report on Intelex. Maintain and distribute updated specifications for products as needed. Assist the Quality Team in determining the annual Quality Program training needs. Required Qualifications & Experience: Bachelor's Degree in Food Science or related field. Min 2-year experience in Food Industry or similar area, preferably Vendor assurance. GFSI/ISO 22000 internal auditor. HACCP internal auditor.,