Executive - Qa

4-5 years

Not Disclosed

Jhagadia

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: IPT Lab Manager

Primary Objective:
Responsible for the analysis, review, and management of the IPT (In-Process Testing) lab and its operations. The role ensures the quality control of finished products, in-process materials, and equipment, while adhering to EHS, GMP, and regulatory guidelines.

Key Responsibilities:

Quality Assurance & GMP Compliance:
- Ensure in-process quality status of finished products, in-process materials, and the environment meet quality standards.
- Provide solutions to quality and hygiene/GMP issues at the shop floor, conducting root cause analysis (RCA) where necessary.
- Perform in-process checks and intermediate product analysis to ensure conformity to specified norms.
- Ensure all testing equipment in the lab is calibrated and performs within required standards.
Team Leadership & Development:
- Build and manage the IPT lab team, ensuring capabilities and stability.
- Recommend structure and roles for the IPT lab and recruit talents as necessary.
- Set goals, coach, and review performance of team members, promoting team development activities.
- Communicate site goals and metrics to the team effectively.
- Provide training on GMP and QMS requirements to both workmen and staff.
Process Management & Improvements:
- Develop and implement SOPs and work instructions based on new QMS requirements.
- Carry out gap analysis for new QMS documents and initiate actions for their implementation.
- Lead the validation process for new and existing equipment in the lab.
- Monitor and report quality trends to the production team, ensuring timely feedback on the analysis of finished products.
Equipment Management & Calibration:
- Ensure all lab equipment operates within calibration norms, with timely performance qualifications.
- Regularly perform calibration of measuring instruments as per specified schedules.
Health, Safety, and Environmental (EHS) Compliance:
- Ensure that the laboratory follows all EHS rules and procedures, maintaining a safe working environment.
- Take responsibility for the upkeep of hygiene, cleanliness, and safety in the lab.
- Report and address any unsafe practices, ensuring zero injuries related to non-compliance with EHS guidelines.
Deviation Management & Troubleshooting:
- Conduct root cause analysis for deviations and provide solutions in collaboration with manufacturing and engineering teams.
- Actively participate in troubleshooting and managing quality-related issues on the shop floor.
Retention Samples & Reporting:
- Oversee the collection and management of retention samples according to Abbott Nutrition (AN) policy.
- Ensure timely and accurate analysis of finished products in shifts for market release.
Opex & Capex Management:
- Support in the preparation of Opex and Capex budgets for the in-process function.
- Propose and closely follow up on the execution of new and ongoing projects.

Required Qualifications and Experience:

Education:
- Postgraduate or Bachelor’s degree in Chemistry, Dairy Chemistry, Food Science, or a 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.
Skills & Knowledge:
- Strong knowledge of analytical procedures, equipment operating methods, and Quality Management Systems (QMS), including FSSC 22000 requirements.
- Hands-on experience with GLP, GHP, GDP, and cGMP practices.
- In-depth understanding of quality checks for both finished and in-process products.
Competencies:
- Strong decision-making and interpersonal skills to collaborate effectively with internal and external teams.
- Ability to handle complex quality and hygiene/GMP issues and provide feasible solutions.
- Strong leadership skills to manage a team, develop talent, and drive team performance.
- Experience with managing equipment calibration, performance qualifications, and process validations.

Accountability & Scope:

Operational Accountability:
- Manage the day-to-day activities of the IPT lab, ensuring compliance with quality standards and safety protocols.
Reporting & Performance:
- Ensure accurate reporting of quality trends, deviations, and troubleshooting efforts.
- Provide recommendations for process improvements and ensure high reproducibility of results.
Compliance & Governance:
- Ensure adherence to all relevant regulatory, GMP, and safety guidelines, including timely completion of audits and performance qualifications.

This position is critical in ensuring that all in-process testing and quality checks meet Abbott's standards. The IPT Lab Manager is responsible for ensuring the lab operates efficiently, equipment is calibrated correctly, safety standards are met, and the team is equipped to handle quality issues on the shop floor. The role requires a balance of technical knowledge, leadership skills, and a strong commitment to quality and safety.

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Executive - Qa

Job Description

Job Title: IPT Lab Manager

Key Responsibilities:

Required Qualifications and Experience:

Accountability & Scope:

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