Instagram
youtube
Facebook

Production-Operator (Osd)

6-9 years
Not Disclosed
10 Jan. 29, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Production Operator – OSD

Date: 20 Jan 2025
Job Location: S18 FC-OSD Production – Second Floor, Bangalore
Pay Grade: [To be specified]
Years of Experience: 6–9 years

About Syngene

Syngene International is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, safety is a top priority, and we uphold a culture of integrity, quality, and compliance. Employees are expected to strictly adhere to safety guidelines, procedures, and standard operating protocols (SOPs).

Core Purpose of the Role

The Production Operator – OSD (Oral Solid Dosage) is responsible for the operation, troubleshooting, setup, and cleaning of manufacturing equipment used in granulation, compression, and coating processes. The role requires expertise in handling production activities, maintaining compliance with regulatory guidelines, and supporting audit readiness.

Key Responsibilities

Manufacturing Operations

  • Operate and manage granulation, compression, and coating processes.
  • Handle machine setup, troubleshooting, operation, changeover, and cleaning of manufacturing equipment, including:
    • Fluid Bed Processor (FBP)
    • Rapid Mixer Granulator (RMG)
    • Roller Compactor
    • Fluid Bed Wurster Granulator/Coater
    • Tablet Coating Machine
  • Conduct in-process quality control (IQQC) tests using:
    • Halogen Moisture Analyzer
    • Tap Density Apparatus
    • Sieve Shaker
    • Hardness Tester

Compliance & Documentation

  • Ensure compliance with Good Documentation Practices (GDP), Current Good Manufacturing Practices (cGMP), and Data Integrity (ALCOA+) principles.
  • Maintain records and documentation for batch manufacturing processes.
  • Support internal and external audit preparation and compliance.
  • Follow safety protocols and ensure adherence to environmental, health, and safety (EHS) guidelines.

Audit & Housekeeping

  • Maintain cleanliness and organization of the production area as per client visit and audit requirements.
  • Participate in internal and external client visits and audits.
  • Ensure compliance with regulatory guidelines and quality standards.

Leadership & Collaboration

  • Provide technical guidance and troubleshooting support in manufacturing operations.
  • Collaborate with cross-functional teams to ensure smooth production activities.
  • Maintain effective communication and support process improvements.

Skills & Competencies

Technical Skills

  • Expertise in granulation, compression, and coating processes in pharmaceutical manufacturing.
  • Hands-on experience with manufacturing equipment such as FBP, RMG, Roller Compactor, Fluid Bed Wurster Granulator/Coater, and Tablet Coating Machines.
  • Knowledge of IQQC instruments including Halogen Moisture Analyzer, Tap Density Apparatus, Sieve Shaker, and Hardness Tester.
  • Strong understanding of cGMP, GDP, and Data Integrity (ALCOA+) principles.
  • Experience in audit handling and compliance requirements.

Behavioral Skills

  • Good communication skills to interact with internal teams and auditors.
  • Strong troubleshooting abilities for manufacturing equipment and process issues.
  • Attention to detail and ability to work in a structured, compliant environment.
  • Ability to handle multiple tasks efficiently while maintaining quality standards.
  • Team player with the ability to support and mentor colleagues.

Education & Experience

  • Education: Diploma in Pharmacy, Engineering, or any related field, or a Bachelor’s degree in any stream.
  • Experience: 6–9 years in pharmaceutical manufacturing and production of oral solid dosage forms.

Syngene Core Values

All employees are expected to demonstrate alignment with Syngene’s core values:

  • Excellence
  • Integrity
  • Professionalism

Equal Opportunity Employer

Syngene is an equal opportunity employer, committed to providing a diverse and inclusive workplace. The company complies with all applicable non-discrimination laws and provides reasonable accommodations for qualified individuals with disabilities.