AstraZeneca is a Science-Led Company, committed to bringing powerful range of innovative drugs to patients’ that meet their needs in important areas of health care. Our focus on innovative science is majorly in therapy areas of Cardiovascular & Metabolic diseases, Respiratory and Oncology. Our business believes in bringing great talent together with opportunities that provide the proper combination of professional environment, job content, and growth potential.
Job Title : Associate Pharma Production (Manufacturing)
Job Reference : R-009520
Location : Yelahanka, Karnataka, India
Be the GMP Subject Matter Expert, lead the team to ensure all production related activities are conducted in accordance to local GMP requirements, and 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.
Compliant Management: Support Investigation in case there are complaints involves production.
Qualification and Validation Documentations: Responsible for reviewing related qualification and validation documentations
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.
Ensure contracted services is delivered within production area as per requirement.
Support Production Manager in delivering process as per agreed performance matrix. Under production manager leadership, ensure regular review for continuous improvement takes place
Driver 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