AstraZeneca Job Vacancy for B Pharma/ M Pharma
locations: India - Yelahanka
time type: Full time
posted on: Posted 2 Days Ago
job requisition id: R-140066
At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. Making the impossible a reality can mean taking a chance on an idea and investing in our exceptional capacity for innovation and discovery. We champion trying new things, and we nurture a test and learn culture that means we are always progressing close to our goals. If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us.
Brief Job Description
Assistant Manager, Production is a role within the Production Team to deliver manufacturing, packing and Institutional business rework activity at CWH Process. This role manages the team to produce high quality product in accordance with the required standards and processes.
Key Working Relationship
Internal (AZ or Team)
• Quality Assurance & Quality Control
• Supply Chain & Distribution
• Engineering & SHE
• Technical Services
• Finance and Procurement
• Human Resources External (to AZ)
• 3rd party suppliers or services provider
• Regulatory Authorities
Education, Qualification and Experience
Essential
Bachelor of Pharmacy/Master of Pharmacy
Experience in formulation & packing environment (OSD) (Handling of wet granulation process, compression machines, coating, Uhlmann/IMA PG blister lines)
4-5 years of experience and knowledge of the pharmaceutical industry
Sound understanding & expertise in technical aspects of pharmaceutical manufacturing & packing operations.
Good understanding of shop floor demography and human behavioral attributes.
Strong oral and written communication skills in English.
Desirable:
Strong quality mind-set.
Work experience in Qualification and validation activities.
Good in presentation and computer skills.
Report and SOP writing skills
Responsibilities:
Compliant way of working
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.
Manufacturing / Packing 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.
AZ Supply System
Be the champion of AZ Supply System, work together with Operational Excellence Lead to ensure coaching is given to team members on principles and desired behaviours, led by example and to drive lean leaderships across all levels within Production Team.
Complaint Management:
Actively participating in periodic complaint process improvement meeting
People/Team Management
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.
Focus on people, engage with the team and to drive team understanding of AZ values.
Lead by example, work cross functionally and to deliver Plant Level objectives.
Ensure contracted services is delivered within production area as per requirement.
Process Management:
Support Production Manager in delivering process as per agreed performance matrix. Under Production Manager leadership, ensure regular review for continuous improvement takes place.
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.
Asset Management and Planning:
Ensure calibrated, validated, maintained equipment are available for production.
Accountable for managing materials, including raw materials, packaging materials, waste, consumables, within Production Team area with respect to GMP requirements.
Responsible for providing inputs to the asset planner and maximise throughput based on asset capacity.
Resources Management:
Coordinate with Finance, Engineering on Capital and Revenue budget planning for Production Function. Ensure all activities/projects within production area is delivered within agreed budget.
Clear view on manpower requirement and work with Human Resources on manpower resources planning.
SHE responsibility
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
Quality overview
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.
Professional Knowledge and Skills
Thorough understanding of GMP and quality management system
Familiar with process and equipment
Deviation and change control management
Audit skills
People Management
Typical Accountabilities (per AZ framework)
Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards 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 and Standards, (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.
Manager Accountabilities at AstraZeneca include Ethical Conduct and compliance,Team Management, Performance Management, Individual Development Planning,Talent Management, Recruitment, People information, SHE accountabilities, and
Fiscal and Financial awareness.
Leaders with accountability for GXP areas are expected to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improve its effectiveness.
Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
Date Posted: 07-Jun-2022
Closing Date: 06-Jul-2022
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