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Officer - Qa Operations

2+ years
Not Disclosed
10 Dec. 16, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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: Officer - QA Operations
Location: India - Jhagadia
Category: Quality


Primary Objective:
The Officer - QA Operations is responsible for managing the quality assurance function at third-party packing stations, ensuring the implementation of Abbott's quality and compliance requirements. The role ensures that both incoming packing materials and outgoing finished products meet Abbott’s quality standards.

Major Responsibilities:

  • Oversee the packing process to ensure compliance with Abbott Nutrition (AN), statutory, and regulatory requirements at the secondary packing station.
  • Develop and implement incoming quality acceptance plans and manage the batch release process for finished products.
  • Foster strong interpersonal relationships across functions, ensuring quality and GMP compliance across equipment, manufacturing areas, warehouses, and dispatch vehicles.
  • Collect and analyze packing materials as per the sampling plan, release materials through SAP, and inform relevant stakeholders of deviations.
  • Ensure labels are current, approved, and applied correctly during label changeovers.
  • Implement GMP, GHK, GDP, and Pest Control plans effectively, driving continuous improvement.
  • Conduct routine internal audits, identify opportunities for improvement, and develop Quality Matrix for monthly/quarterly management reviews.
  • Ensure adherence to EHS rules, report incidents/near misses, and actively promote a safety-conscious environment.
  • Provide leadership in identifying procedural violations and ensure zero injuries within the team.
  • Promote environmental sustainability by identifying opportunities to reduce energy, water use, and waste generation.

Education & Background:

  • Postgraduate in Chemistry/Dairy Chemistry/Food Science with 2-3 years’ experience in the food industry, or
  • Graduate in Chemistry/Food Science with 4-5 years’ experience in the food industry, or
  • Master’s in a relevant field.
  • Knowledge of analytical procedures, quality management systems (FSSC 22000), GMP, and safety aspects of QA labs.
  • Hands-on experience with GLP, GHP, GDP, and cGMP.

Accountability & Scope:

  • Responsible for finished product quality release at TPM locations.
  • Develop SOPs for TPM sites, review quality performance based on KPIs, and support continuous improvement initiatives.
  • Ensure compliance with FSSAI and ISO 22000 requirements, and manage internal and external audit schedules.
  • Monitor and review quality systems, including CAPA, market complaints, change controls, deviations, and pest management systems.
  • Provide expertise on packaging design trials and assist in the preparation/update of product specifications.
  • Maintain records management systems, ensuring retention and retrieval procedures align with corporate and regulatory standards.
  • Promote a strong governance framework with vendors and ensure food safety compliance (FSSC 22000 & FSSAI) at TPM sites.