Location – Uttarakhand
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Job Opportunity: Enhance Lives as a Quality Assurance Expert at Abbott!
Company Overview: Join Abbott, a global healthcare leader dedicated to empowering individuals to live their lives to the fullest at every life stage. With a remarkable portfolio of life-transforming technologies spanning diagnostics, medical devices, nutritional’s, and branded generic medicines, Abbott is making a profound impact on healthcare worldwide. Our team of 109,000 colleagues serves people across more than 160 countries.
Your Role in Our Journey: Are you an experienced and skilled professional in the realm of Pharmaceutical Quality Assurance? We’re seeking an exceptional individual to bolster our team. As a part of our renowned organization, you’ll bring your expertise in managing quality across diverse dosage forms. Your familiarity with GxP, Schedule M, and ICH requirements will be a crucial asset. An adept grasp of quality management systems, risk assessments, investigations, CAPA, and compliance will be instrumental in your role. If you have hands-on experience with Injectable products, that’s a valuable bonus. Your ability to communicate effectively—both in writing and verbally—paired with your adeptness at stakeholder management, will be pivotal to your success.
Key Responsibilities:
- Lead the oversight of Quality operations and ensure GMP compliance for TPM’s of Contract Operations in India.
- Foster collaboration between Abbott quality management and site quality management to implement Quality Projects at TPM’s as required.
- Guarantee regulatory compliance related to labeling, stability studies, and documentation, ensuring impeccable quality products reach consumers from TPM sites.
- Spearhead on-site investigations of market complaints in tandem with site teams, conducting in-depth root cause analysis and tracking the effectiveness of action plans to ensure timely closure.
- Hold accountability for the efficacy of Abbott SOPs and quality technical agreements at contract manufacturing sites, promptly escalating concerns to Abbott management when necessary.
- Identify training needs for team members and sites based on observations, and provide targeted training.
- Review and meticulously manage OOS, deviations, incidents, and change controls for Abbott products, ensuring exhaustive investigations and the successful closure of identified CAPAs.
- Lead the timely implementation of Pharmacopeial changes for Abbott products.
- Maintain a state of quality and compliance for associated TPMs, ensuring prompt closure of audit-related CAPAs.
- Prepare quarterly performance scorecards for TPMs and ensure adherence to action plans.
Why Abbott: At Abbott, you’ll be part of a dynamic global team with a mission to improve lives through cutting-edge healthcare solutions. Our commitment to innovation, quality, and collaboration ensures that every role is meaningful and impactful. Join us in making a difference today!
Application Details: If you’re a dedicated Quality Assurance professional with a passion for excellence and a proven track record, we invite you to apply. This is your opportunity to thrive within a leading global healthcare organization while contributing to our mission of enhancing lives worldwide.
Please note that the information provided is a creative representation and not an actual job description from Abbott. It’s important to use official job descriptions when applying for positions.
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