Officer - Qa Operations

2+ years

Not Disclosed

Remote

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.

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Officer - Qa Operations

Job Description

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