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Job in Technical Services as Assistant Manager at AstraZeneca

 

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AstraZeneca is one of the world's leading pharmaceutical companies, with a broad range of medicines designed to fight disease in important areas of healthcare. Backed by strong science and wide-ranging commercial skills, we are committed to sustainable development of our business and the delivery of a flow of new medicines that bring benefit for patients and add value for wider society.

Post : Assistant Manager Technical Services

Job Description

  • Takes responsibility for the technical evaluation and establishment of manufacturing processes for specified products within the AstraZeneca portfolio.
  • Takes responsibility and accountability for completion of TT programs with Pro-active co-ordination with production team.
  • Co-ordinates with the Supply Chain and other supporting function to ensure that required materials are available to conduct TT programmes.
  • Assess the likely success and benefits of technologies and gains support and commitment to these opportunities from senior management.
  • Recognises where there are gaps between business needs and known and emerging technologies and participates in the development of strategies to close technology gaps
  • Provides rapid technical support and direction for product governance across the portfolio. Also accountable for providing response to key business implications like technical transfers, transportation needs, lean initiatives, stability requirements, product complaints , investigations change parts development and harmonisation activities.
  • Translates business proposals into costed options for product design, balancing various influencing factors, such as commercial and quality requirements, suppliers' capabilities, manufacturability, storage/distribution needs and regulatory compliance.
  • Ensures that work within function is performed in accordance with Safety, Health and Environment requirements , GMP and fiscal requirements
  • Develops, implements and reports against key performance indicators which define the performance of own section
  • Responsible for change management and deficiency handling of manufacturing operations.
  • Participate actively in vendor evaluation process and monitoring the CAPA plan with respect to that vendor for technical related activities.
  • Identifies, evaluates, recommends and selects technical options to be adopted as global standards

 

Minimum Requirements
Review approve URS for process equipments
FAT Documents review
Review of Qualification documents
Review of OCM’s
Execute OCM’s Action Items

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Validations
Prepare validation master plan & Review
Cleaning Validations
Plan preparation
Review the validation plan
Cleaning Validation Matrix preparation & review
Review & Approve of OCM’s
Execute OCM’s Action Items
Ensure the TS related SOP’s are aligned with  QCM Guidelines
SOP Preparation and review

Additional info:
Location: Karnataka
Job Type: Technical Services
Industry type: Pharma

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