AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
Post : Assistant Manager - Production
• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies on time. Report potential issues of non-compliance.
• Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.
• Ensuring GMP Compliant Production
• Be the GMP subject matter expert, lead the team to ensure all production related activities are conducted in accordance to local GMP requirements, support Quality Team in implementing global standards in local operation sites.
• Change control : Responsible for initiating change, completing impact assessment, executing and to close up change.
• Deviation management : Responsible for raising, investigating of deviations.
• CAPA management : Responsible for CAPA completion.
• Standard Operating Procedures (SOP) management :
• Be the author of operational level SOP.
• Responsible for reviewing relevant SOPs, as well as ensuring training is provided for the team.
• Act as second review of master batch record.
• Receive and review batch record, and submit record on time for quality team review.
• Complaint Management : Support investigation in case there are complaints involves Production.
• Qualification and Validation Documentations : Responsible for reviewing related qualification and validation documentations.
• Work together with Production Manager and Operational Excellence Lead to ensure coaching is given to team members on principles and desired behaviours, deliver specific initiatives to drive understanding of AZ Supply System across the team.
• Actively participating in periodic complaint process improvement meeting
• Drive production team performance and responsible for delivery of the daily/monthly production targets as per Monthly Production Plan.
• Develop the team, by ensuring training plan and skill matrix are up to date.
• Develop other departments on formulation knowledge
• Drive technical training of formulation equipment
• Focus on people, engage with the team and to drive team understanding of AZ values.
• Ensure contracted services is delivered within production area as per requirement.
• Support Production Manager in delivering process as per agreed performance matrix. Under Production
• Drive standardised way of working by ensuring process adherence.
• Focus on capability, ensure sufficient training is given to team members to deliver process activities as per required standards.
• Support and provide inputs for Process Validation documentation preparation and execution.
• Verification of asset being calibrated and ready for production.
• Support, provide inputs and review machine qualification documentation during preparation and execution phases.
• Responsible for managing materials, including raw materials, packaging materials, waste, consumables, on the shop floor with respect to GMP requirement.
• Ensure all activities/projects within production area is delivered within agreed budget and agreed manpower allocation.
• Act as a SHE member and promote SHE within the area of responsibility and ensure that SHE considerations are incorporated into all activities;
• Review SHE performance and provide advice and recommendation;
• Support and guide improvements on SHE performance within production;
• Ensure adequate resources are allocated to SHE issues
• Ensure that roles, responsibilities and reporting lines are clearly defined throughout the organisation, to assure a functionally independent quality unit.
• Ensure sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-going professional development to maintain proficiency.
• Ensure continuing suitability and effectiveness of the quality management system, product quality and GMP/GDP compliance through participation in management reviews and through advocating continual improvement.
• Graduation / Post Graduation (Pharmacy, chemistry or Chemical Engineering preferred).
• Knowledge of good manufacturing practice, safety, health and environment and lean manufacturing.
• 6-12 years of experience and knowledge of the pharmaceutical industry (higher the better)
• Proven ability to manage multiple projects/tasks effectively.
• Strong oral and written communication skills in English and preferably Kannada. Telegu language knowledge will help.
• Experience in manufacturing environment.
• Good communication skills.
• Strong quality mind-set.
• Work experience in Qualification and validation activities.
• Good in presentation and computer skills.
• Interest to learn new technologies and processes.
• Computer Skills required
• Inclination towards learning Lean and working in cross-functional environment
• Thorough understanding of GMP and quality management system
• Familiar with process and equipment
• Deviation and change control management
• Audit skills
• People management
Location : Yelahanka, Karnataka
Qualification : B.Pharm, B.Sc, M.Pharm, M.Sc
Industry Type : Pharma
Functional Area : Production
End Date : 20th June, 2020
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