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Officer - Qa Operations

4-5 years
Not Disclosed
10 Dec. 30, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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: Quality Assurance Manager - Third Party Packing Station

Primary Objective:
Responsible for managing the quality assurance function at the third-party packing station. Oversee quality and food safety programs, implement Abbott's quality and compliance requirements at the packing station, and ensure all incoming packing materials and outgoing finished products meet quality standards.


Key Responsibilities:

  • Quality Compliance:
    Ensure that product packing aligns with Abbott Nutrition (AN), statutory, and regulatory quality requirements at the secondary packing station.

  • Quality Acceptance & Batch Release:
    Establish incoming quality acceptance plans and be accountable for the batch release of finished products.

  • Process and Hygiene Management:
    Oversee the quality of in-process materials, finished products, and hygiene/GMP standards at process equipment, manufacturing areas, warehouses, factory premises, and dispatch vehicles from the third-party plant.

  • Packaging Material Management:
    Collect packing materials according to the sampling plan, perform accurate analysis, and release materials through SAP. Actively inform the supervisor and stakeholders of any deviations.

  • Label and Packaging Compliance:
    Coordinate label changeovers and ensure the current and approved labels are applied correctly.

  • Continuous Improvement & Compliance:
    Implement and drive continuous improvements in GMP, GHK, GDP, and pest control plans. Conduct internal audits and identify areas for improvement.

  • Quality Performance Monitoring:
    Develop and share a Quality Matrix during monthly or quarterly quality management reviews. Monitor the performance of third-party packaging sites based on KPIs and reports.

  • Safety and Compliance:
    Ensure adherence to all environmental, health, and safety (EHS) rules and procedures. Lead efforts in reducing energy, water use, and waste generation within the work area.

  • Training & Development:
    Ensure that self and team members consistently follow EHS procedures and are compliant with training requirements. Identify operational training needs and coordinate training delivery when required.


Required Qualifications and Experience:

  • Education:

    • Postgraduate in Chemistry, Dairy Chemistry, Food Science, or related field with 2-3 years of experience in the food industry, OR
    • Graduate in Chemistry/Food Science with 4-5 years of experience in the food industry, OR
    • Master’s in a relevant field.
  • Skills & Knowledge:

    • In-depth knowledge of analytical procedures and equipment used in quality assurance and quality management systems (e.g., FSSC 22000, GMP, GLP, GHP, GDP, cGMP).
    • Familiarity with safety and quality regulations in the food processing industry, including FSSAI and Legal Metrology Act, Rules, and Regulations.
    • SAP knowledge, particularly in the Quality module.
    • Experience in handling packaging design trials and supporting packaging SMEs.
  • Competencies:

    • Strong interpersonal and communication skills to build healthy relationships across functions.
    • Decision-making abilities in managing in-process quality status and resolving complex quality or hygiene/GMP issues.
    • Ability to conduct risk assessments and implement corrective actions for quality and safety issues.

Key Accountabilities & Scope:

  • Finished Product Quality Release:
    Accountable for the quality release of finished products for third-party manufacturing (TPM) locations.

  • SOP Development and Review:
    Develop and maintain SOPs for TPM to ensure consistent quality expectations.

  • Quality Incident Management:
    Support TPM in investigating quality incidents, developing corrective and preventive actions (CAPA), and resolving market complaints.

  • Audit & Compliance:
    Support internal and external audits, ensure compliance with Abbott's systems and regulatory standards, and manage document retention for the site.

  • Risk Management:
    Prioritize quality activities based on risk assessments and ensure governance for vendors associated with the site to maintain compliance.


This role is vital in maintaining high standards of product quality, ensuring regulatory compliance, and driving continuous improvement in third-party packing operations. The manager will collaborate with internal and external stakeholders, oversee packaging material management, implement robust quality systems, and lead efforts to address quality-related issues.