AstraZeneca Chemistry & Pharma Job Vacancy 2022 – Apply Online
AstraZeneca Hiring chemistry and pharmacy candidates. B Pharma and BSc Chemistry candidates. Candidates with bachelor’s dgeree in chemistry and pharma may apply for the job vacancy at Asterzeneca for the post of Senior Quality Supplier Manager. Chemistry and pharma job vacancy 2022, Intrested and eligible candidates may check out all the details on the same below:
Job Title: Senior Quality Supplier Manager
Location Bengaluru, Karnataka, India
Job ID R-140890
Eligibility Criteria:​
Bachelor’s degree in a science / technical field such as Pharmacy, 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 a 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 a combination of Quality and Technical
- Masters’s Degree in Quality Assurance/Regulatory Affairs or other advanced scientific fields
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 the Supplier’s 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 the 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 the right product at the right time is delivered into the Product Supply Chain.
- Proactively ensures the 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.
Click Here To Apply Online
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