Divisional Supplier QA Contingent Worker
Job Description:
๐จ Hiring: Divisional Supplier QA | Pharma
๐ Location: BKC, Mumbai
๐ข Division: Established Pharmaceuticals Division (EPD)
๐ผ Employment Type: Autorenewal Contract
๐ค Payroll: Talisman HR Solutions
๐ Working Hours: 9:00 AM – 5:00 PM
๐
Working Days: 5 Days a Week
Primary Job Function:
- Support in ensuring compliance is maintained and business needs supported. Any areas of risk to product quality, patient safety, or market supply are managed directly by this position, including establishment and execution of appropriate actions and communication to senior leadership.
- Provide QA activities for suppliers ensuring compliance to applicable regulatory requirements and Quality Agreements and in co-operation with all relevant functions.
- Support by coordinating with the suppliers & internal stakeholders on the quality related activities at Suppliers producing divisional products on behalf of Abbott, to ensure safe, efficacious, and quality product can be supplied in accordance with regulatory and business requirements.
To ensure that divisional suppliers maintain compliance with applicable regulatory requirements and Quality AgreementsCore Job Responsibilities:
- Develop and consistently execute a quality strategy for divisional suppliers to assure business objectives are met while assuring compliance to applicable regulatory requirements and Abbott policies.
- To ensure that the commitments of the Quality Agreements are being fulfilled and help facilitate resolution in cases where they are not.
- Support in goals with cross-functional/divisional scope ensuring alignment with EPD business strategy.
- Participate in QA cross-functional teams to support suppliers including active participation in Business Management Reviews, as necessary.
- Assure compliance of all divisional products & materials manufactured at suppliers.
- Act as the quality review for significant supplier exception events for impact on product quality, safety, efficacy, and impact to the regulatory filing.
- Develop and maintain an appropriate Quality Management Review program and Quality Performance Measurements for Suppliers, which identify and address quality, operational, and organizational issues.
- Provide expert knowledge on all relevant regulations and standards and maintain such knowledge current.
- Promote continuous improvement, innovation, simplification aligned with Abbott and EPD strategy.
- Embed and drive appropriate risk-based decision making.
- Management of Approved supplier List
- Management of change control
- Support in arranging supplier related documents.
Position Accountability/Scope:
This position is responsible and accountable for:
- Providing QA expertise for Divisional suppliers that produce Divisional products for EPD.
- Ensuring that divisional suppliers maintain compliance with the Quality Agreements and local and international regulations as required by markets supplied and ensuring that the quality systems are appropriate so that the product safety, efficacy, and quality are maintained.
- Decision making as it pertains to quality issues for products manufactures at suppliers impacting EPD business and strategy.
๐น Candidate Requirements:
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B.Pharm / M.Pharm / Master's Degree in Science
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7–10 years of experience in the pharmaceutical industry.
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Strong knowledge of pharmaceutical manufacturing and testing operations.
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Experience in Supplier QA / Vendor QA / External Manufacturing QA preferred.
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Good knowledge of GMP, CAPA, Change Control, Quality Systems, Risk Assessment and Regulatory Compliance.
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Excellent verbal and written communication skills.
๐ฉ Interested candidates can share their updated CV at:
careers@talismanstaffing.com or contact- Sakshi for more details
Company Profile
Our client is an American MNC Pharmaceutical Company.
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- Interested candidates are requested to apply for this job.
- Recruiters will evaluate your candidature and will get in touch with you.