Gujrat, PB, India

Manager-GMP and Compliance (Process)

 Job Description:

JOB SCOPE

Role : Manager - GMP and Compliance (Process)

Primary Function/Primary Goals/Objectives:

Provide overall leadership to the operations team on GMP & compliance

Responsible for planning, execution, monitoring, and overall supervision of safeguard ( Protecting the product, GMP compliance ) related initiatives ensuring Abbott Standards.

The primary purpose of the role is to focus on the highest standard of food safety, GMP, Hygiene, Quality & system complaints. Drive projects/actions related to continuous improvement in the same.

Describe the primary goals, objectives or functions, or outputs of this position.

Responsibilities

  • To ensure the highest standards of GMP & hygiene compliance in Manufacturing
  • To drive a culture of food safety and quality at shopfloor by developing a system and monitoring plan
  • Promote and foster good human relations within the department & plant-wide and work to ensure that employees embrace Abbott Values.
  • To assume responsibility for improving efficiency and quality in manufacturing operations.
  • Ensure periodic review of maintenance programs for all equipment & facility to the highest level of food safety and hygiene.
  • Ensure no operational impacts due to GMP and compliance-related issues
  • Drive the Business Excellence Program and Lean/Sigma continuous improvement initiatives in the department. (RCA, OSW, etc.)
  • Action execution of standardized non-routine cleanings / risk assessment /mitigation, in line with revised EMP policy
  • Non-routine detects investigation, corrective & preventive actions
  • Global CAPA assessment & execution
  • Proactive execution of preventive actions to avoid POP events in line with revised safeguard policy
  • Documentation in line with global safeguard policy compliance
  • Identify GMP improvement actions, closure, monitoring for compliance & sustenance
  • GMP maintenance work order optimization & change management compliance
  • Provide relevant training to teams to educate & motivate employees to maintain the Highest level of Food safety and compliance.
  • Lead and manage specific projects as required.
  • Timely reporting of Safety, Quality, Food Safety & People related incidents.
  • Ensure 5S & safe working across areas of operations, cleaning & sanitizing chemicals storage & handling.
  • To analyze Root Cause and execute CAPA for all events & GMP observatuion & complaints in area.
  • To ensure 100% adherence to SOPs for operations, cleaning & hygiene maintenance
  • To handle internal & external audits & compliance reviews. Ensure compliance with food safety related concerns in Manufacturing
  • To engage self & operation's team on continuous improvement of overall operations.
  • Take responsibility for the career development /planning and performance discussion of the team members by continuous training/coaching of shift crew in the span of control.

JOB REQUIREMENTS

  • Bachelor of Science Degree in Dairy Technology/Mechanical Engineering/Food science/ Microbiology with minimum 2-5 yrs experience or Diploma with relevant equivalent experience
  • Sound people management skills.
  • Good understanding of production and/or material operations. knowledge of planning and forecasting techniques.
  • Knowledge quality & Food safety system.
  • Being proficient in Gujarati is an added advantage.
  • The ability to organize, motivate and develop employees.
  • Interpersonal skills to have a healthy relationship with colleagues working in different functions at the site.
  • Communication skills to understand and provide necessary feedback or solutions to the site team and internal customers.
  • Strategic thinking to go in-depth understanding of Site Operations and related complex issues and provide the best feasible solutions at all levels. Should possess sound analytical skills.
  • Decision-making skills to handle the different problems at the Site.
  • Provide overall leadership operations team on GMP & compliance
  • Responsible for planning, execution, monitoring, and overall supervision of safeguard ( Protecting the product, GMP compliance ) related initiatives ensuring Abbott Standards.
  • The primary purpose of the role is to focus on the highest sandard of food safety, GMP, Hygiene, Quality & system complaints. Drive projects/actions related to continuous improvement in the same.
  Required Skills:

5S GMP Career Development Strategic Thinking Nutrition Mitigation Food Safety Closure People Management Decision-Making ROOT Investigation Analytical Skills Risk Assessment Healthcare Change Management Reviews Continuous Improvement Optimization Storage Interpersonal Skills Forecasting Coaching Manufacturing Documentation Planning Maintenance Leadership Engineering Business Communication Science Training Management