Sr Officer Production And Process Compliance - India

Overview

POSITION SUMMARY

The Senior Officer – Process Compliance (Manufacturing) is responsible for ensuring continuous compliance with cGMP and GSP requirements and the sustainability of checks, controls, and CAPAs implemented across manufacturing lines at Contract Manufacturing (CM) sites.This role involves providing training to CM personnel in line with Herbalife requirements, managing and reviewing investigations to ensure correct root cause identification, verifying the effectiveness of CAPAs, tracking open investigations, and providing routine status updates to management.

KEY RESPONSIBILITIES

cGMP & GSP Compliance

• Ensure adherence to cGMP and GSP requirements at all assigned Contract Manufacturing sites.
• Monitor and oversee shop floor activities to maintain quality and compliance standards.

Shop Floor Monitoring

• Conduct routine GMP rounds across shop floors, warehouses, and service areas.
• Review manufacturing and packaging operations to ensure compliance with Herbalife standards.
• Verify and monitor in-process parameters for:
  • Powder manufacturing and packaging
  • Granulation
  • Compression and coating
  • Capsule filling
  • Tablet and capsule counter filling
  • Stick packing operations
• Provide hands-on support to CM teams for troubleshooting issues encountered during manufacturing and packaging.
• Design, draft, review, and maintain batch manufacturing and packaging documents.

Investigations & CAPA Management

• Manage, facilitate, document, and review investigations to ensure:
  • Accurate root cause analysis
  • Implementation of effective corrective and preventive actions (CAPA)
  • Compliance with cGMP and business requirements
• Conduct investigations for non-conformances in coordination with CM partners and Herbalife cross-functional teams.
• Support CM teams in identifying appropriate CAPAs and ensuring proper implementation.
• Verify the effectiveness and sustainability of implemented CAPAs.
• Track open investigations and action items, ensuring timely closure.

Reporting & Communication

• Compile and document daily shop floor observations and CAPA status.
• Provide regular updates on manufacturing investigations to project teams, clients, and management.
• Manage client involvement during investigations as required.

Process Improvement & Visual Management

• Drive visual management systems to track investigation progress and ensure adherence to timelines.
• Escalate delays or critical issues appropriately to maintain compliance with defined timelines.
• Coordinate and organize cross-functional resources to support investigation activities.
• Delegate responsibilities across functions to ensure effective investigation closure.

Operational Excellence (OpEx) Support

• Support the OpEx team by:
  • Delivering training to CM teams
  • Verifying closure of action items
  • Assessing the effectiveness and long-term sustainability of implemented improvements

MINIMUM QUALIFICATIONS

Education

• Graduate in Mechanical Engineering with experience in the Food Industry

SKILLS & COMPETENCIES

• Strong result-oriented mindset with the ability to drive completion.
• Effective team player with the capability to lead shop floor teams.
• Proficient in Microsoft Office applications (Word, PowerPoint, Excel).
• Strong written and verbal communication skills.

EXPERIENCE

• 3–5 years of relevant industry experience.
• Industry exposure: Pharmaceutical / Nutraceutical / Food.
• Experience in Quality Assurance (QA) will be added advantage.