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 : Packing Manager
Job Description
Packing Manager is a leader for the Packing Process Operation and manages the team to produce high quality product in accordance with the required standards and processes.
Typical Accountabilities:
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 packing related activities are conducted in accordance to local cGMP requirements, support Quality Team in implementing global standards in Bangalore packing operations.
• Change control: Accountable and responsible for completing impact assessment, reviewing risk assessment, executing change and be the area approver of changes.
• Deviation management: Responsible for raising, investigating, reviewing deviations, as well as approval of deviations.
• CAPA management: Accountable and responsible for CAPA completion within timelines.
• Standard Operating Procedures (SOP) management :
* Be the author and trainer of high level SOP.
* Responsible for review, approve relevant SOPs, as well as ensuring training is provided for the team.
• Manufacturing Record: Act as second reviewer and approver of master batch record.
• Compliant Management: Responsible for reviewing and signing off investigation report for complaints involving Production.
• Qualification and validation documentation: Responsible for reviewing qualification and validation related documents
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.
People/Team Management
• Lead by example, work cross functionally and to deliver Plant Level objectives.
• Drive packing team performance and accountable for the delivery of Monthly Production Plan, as well as manpower plan.
• Develop the team, ensuring each team member has a specific role with clear individual objectives and development plan.
• Focus on people, engage with the team and to drive team understanding of AZ values.
• Ensure team members attend GMP/SHE/compliance training as required, and only trained personnel are allowed to operate/deliver tasks.
• Be accountable for skill matrix compliance of team members.
Process Management
• Be the process owner of packaging process. Accountable for the process performance, ensuring regular review for continuous improvement.
• Work collaboratively and cross functionality to ensure other functions understands, supports process activity and its improvement.
• Drive standardized way of working by ensuring process adherence, focus on capability, and ensure sufficient training is given to team members to deliver process activities as per required standards.
• Work closely with third party services provider; ensure contracted services are carried out as per requirement within production area.
Asset Management
• Ensure calibrated, validated, maintained equipments 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.
Quality Overview
• Ensure that roles, responsibilities and reporting lines are clearly defined in production area.
• 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.
SHE
• Ensure Global SHE standard and procedure requirements are fulfilled
• Impart training on SHE standard / procedure to all concerned stakeholders
• Participate in SHE Management system self-inspections and Audits
• Have Annual SHE management system review completed for respective Standard Thorough understanding of GMP and quality management system
• Familiar with packing equipment’s.
• Deviation and change control management
• Audit skills
• People management
Candidate Profile
• Must hold a minimum of a Bachelor’s or Master’s Degree in Pharmacy / BE/Btech Chemical Engineering / BSc with Chemistry as Principal subject
• Minimum of 07-08 years’ experience in the pharmaceutical / bio-pharmaceutical industry, including having significant experience in Good Manufacturing Practices
• Experience in Packing operations (preferably Blister packing) – may be through production, quality, supply chain or any other relevant function
• A good working knowledge of the pharmaceutical industry.
• Excellent communication skills
• Should have people management skills
• Excellent problem solving skills
Additional Information
Experience : 7-8 years
Location : Yelahanka, Karnataka
Qualification : B.Pharm, M.Pharm, B.E, B.Tech
Industry Type : Pharma
Functional Area : Packing
End Date : 30th March, 2020
See All M.Sc Alerts B.Pharm Alerts M.Pharm Alerts Karnataka Alerts
See All Other Jobs in our Database
.png)
