Officer / Executive - Production ( Single Use System)

Job Description:

Key Responsibilities:

1. Adhere to GMP and GDP:

   • Ensure all activities are performed in accordance with SOP (Standard Operating Procedures) and regulatory requirements for GMP and GDP.

   • Maintain compliance with safety, quality, and environmental standards during production processes.

2. Final Quality Check and Approval:

   • Conduct final quality checks and approval for finished products, including components, 2D/3D bags, and liners.

   • Inspect and verify that all products meet quality specifications before release for distribution or shipment.

3. Production Output and Order Execution:

   • Responsible for monitoring and managing production output to meet company targets.

   • Handle item reclassification and ensure timely execution of pending orders.

   • Coordinate with various departments to ensure smooth production flow and reduce delays.

4. Preparation of Strongly Used Assemblies:

   • Ensure proper preparation and production of strongly used assemblies, including 25/30 bags and liners.

   • Monitor assembly line processes and troubleshoot any issues that arise during production.

5. Single-Use Systems:

   • Must have strong knowledge and experience with single-use systems (such as bags, liners, and associated components) to ensure proper installation, operation, and troubleshooting.

   • Oversee the use of single-use systems to optimize product quality and production efficiency, ensuring minimal risk of contamination.

   • Ensure that all single-use components meet regulatory and quality requirements.

6. Participation in Departmental KAI (Key Activity Indicators):

   • Actively participate in departmental KAI initiatives, focusing on improving efficiency and quality.

   • Provide insights and recommendations for enhancing operational performance based on KAI analysis.

7. Document Verification and SOP Compliance:

   • Review and verify all relevant production documents, ensuring they are completed accurately and in accordance with SOPs.

   • Monitor and ensure that all production activities comply with established Standard Operating Procedures.

Skills and Qualifications:

• Education:

  • Bachelor’s degree in Engineering (B.Tech) or a related field.

  • Preference for candidates with a B.Tech in Mechanical, Manufacturing, Industrial Engineering, or similar disciplines.

• Experience:

  • 2+ years of experience in a production or quality control role within a manufacturing environment, with specific expertise in single-use systems.

• Knowledge:

  • Strong understanding of GMP, GDP, SOPs, and single-use systems (including bags, liners, and related components).

  • Familiarity with production systems and quality assurance practices.

• Skills:

  • Detail-oriented with a strong focus on quality.

  • Excellent communication and teamwork skills.

  • Ability to work under pressure and meet deadlines.

  • Proficient in document verification and regulatory compliance.

Key Attributes:

• Strong analytical and problem-solving abilities.

• Ability to adapt to dynamic production environments and changing priorities.

• Commitment to continuous improvement and operational excellence.