AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
Post : Senior Quality Supplier Manager
Job Description :
Key Accountabilities
• Planning for, supporting and participating in Regulatory Agency inspections of their Suppliers and AZ sites (regarding Quality management for supply of external materials to the Sites)
• As needed, perform Quality Audits within their technology area, as a Guest Auditor on the Global Quality Audit (GQA) lead audit team.
• Serve as ESLQ supplier representative n Issue Management Teams
• Provide expert Quality input to New Product Introduction (NPI), Asset Strategy and/or Value Delivery projects. This includes identifying and assessing Suppliers, establishing Suppliers way of working with ESLQ and supporting the Supplier through to regulatory approval.
• Liaise with Suppliers to ensure successful delivery of projects
• Make decisions and advise the Supplier Management Team regarding quality and pharmaceutical technology issues within their area of expertise.
• Responsible for Quality Supplier Management including but not limited to: periodic Quality Risk Assessments; Quality Agreements; trending and reporting of data; assessing, reviewing and supporting improvement of quality systems at Suppliers; attendance at Quality and Business Review Meetings.
• Maintains a high level of understanding of relevant production processes and quality systems.
• Performs the Quality review, assess and/or approval of the following cGMP documentation for their Suppliers, as required:
- Change Requests
- Product Quality Reviews or Supplier Quality Review, as required.
- CMC documentation associated with changes or product establishment at Suppliers, as required.
- Development and technology transfer documentation, along with Director, Supply and Quality Systems, ESLQ
- Quality Investigations (Deviations, Product Quality Complaints)
• Validation Plans, Protocols and Reports, Collaborates with and influences other Quality professionals to ensure consistent application and execution of key quality systems
• Responsible for quality issues escalation and the collaborative resolution at the Suppliers, to ensure right product at the right time is delivered into the Product Supply Chain.
• Proactively ensures correct level of oversight of suppliers GMP and regulatory compliance during the qualification, maintenance and termination phases of projects at their suppliers.
• As a member of a Supplier Management team, responsible for supporting cost saving initiatives, value creation, performance standards, continuous improvements, and issue resolutions at their Supplier(s)
• Collaborates with, and influences, other PCO /assigned area members to facilitate process improvements and risk assessments; benchmarks internal and external Quality practices to identify innovative efficient and effective practices
• Stays abreast of evolving compliance practices and recommends implementation strategies to ESLQ /AZ site leaders
• Collaborates in data analysis and report creation on quality metrics and key performance indicators
• Develops and maintains effective business relationships with Suppliers
• Specific to the support and management of ESLQ QMS, may be responsible for one or more of the following:
• Supporting data provision to Stability Management System.
• Manages quality data and records in relevant quality management support systems as required.
• Assist in the production of, or contribution to, AZ quality documentation (including SOPs, Q & C Manual Procedures, etc)
• Participates in ESLQ self-inspection program, auditing processes and procedures.
• Develops and maintains a high level of understanding of the technical production process and quality systems being utilized within the PCO Supplier Management team
- Accountable for Quality decision-making; works directly with the Supplier Management leader and other team members to deliver objectives
- Ensures compliance with all cGMP Compliance and Regulatory requirements by providing proper coaching, mentoring and consultation to the Supplier Management Team
- Provides functional direction as required.
Candidate Profile :
Essential
• Bachelor degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering (Note: there may be specific additional requirements depending on the regulations in each country). Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role
• Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment. Also strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
• Excellent oral and written communication skills [English and local language(s)]
• Demonstrated experience working cross-functionally and managing significant improvement initiatives (e.g. project management skills)
• Strong problem solving skills
• Strong negotiating/influencing skills
• Ability to work independently under his/her own initiative.
• Ability to travel nationally and internationally as required approximately 25% of their time.
Desirable
• Experience working in a PCO/PET organization or Lean/Six Sigma training.
• Multi-site / multi-functional experience
• Proven experience in Quality Assurance or combination of Quality and Technical
• Masters Degree in Quality Assurance/Regulatory Affairs or other advanced scientific field
Additional Information
Qualification : B.Pharm, B.Sc
Location : Bengaluru, Karnataka, India
Industry Type : Pharma
End Date : 10th July, 2022
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