Digital Quality Systems

2 days ago

Amritsar, Punjab, India beBeeQualitySystemManager Full time ₹ 2,25,30,000 - ₹ 2,51,80,000

Job Description:

">Quality System Manager.
The role of Quality System Manager will evolve from overseeing the implementation of laboratory information management systems (LIMS) and their integration with quality management systems (QMS) and enterprise resource planning (ERP), into a long-term system owner and custodian of digital quality excellence.

This pivotal role will be responsible for managing the lifecycle of quality systems, ensuring regulatory compliance, promoting adoption, and driving ongoing digital transformation across quality and lab operations. The ideal candidate will work cross-functionally with manufacturing, quality assurance (QA)/quality control (QC), IT, and regulatory affairs to enhance efficiency, productivity, and regulatory readiness.

Responsibilities:
- Lead the selection, design, implementation, validation, deployment, maintenance, and support of electronic systems across QA, QC, production, and supply chain (e.g., LIMS, MES, eBMR, ERP, CDS, QMS) across multiple sites.

- Partner with production, engineering, quality control (QC), quality assurance (QA), IT, and operations to define user requirements, workflows, and system improvements.

- Ensure all systems comply with GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity standards.

Skills and Qualifications:
- Mastery of digital quality systems and data governance.
- Strong project and change management skills.

- Excellent communication, leadership, and collaboration abilities.

- Strong knowledge of laboratory workflows and QC operations.

- Strong analytical skills and comfort with reporting and dashboards.">

Required Skills and Qualifications:

">Bachelor's/Master's in Life Sciences, Computer Science, or Pharmaceutical Sciences.,
10+ years industry experience in a GMP-regulated (Pharma/Biotech) environment with experience in LIMS/QMS/ERP systems,
Strong understanding of GxP, 21 CFR Part 11, Annex 11, and CSV principles.
Proven record of system ownership post-implementation and cross-functional leadership.
Mastery of digital quality systems and data governance.,
Strong project and change management skills.,
Excellent communication, leadership, and collaboration abilities.,
Strong knowledge of laboratory workflows and QC operations.,
Strong analytical skills and comfort with reporting and dashboards.">

Benefits:

">Opportunity to drive digital transformation across quality and lab operations,
Work collaboratively with cross-functional teams,
Develop and implement quality systems and processes that meet regulatory requirements,
Enhance efficiency, productivity, and regulatory readiness.">

Others:

">We are seeking a highly motivated tech-savvy QA specialist with expertise in software and digital systems implementation to join our biopharmaceutical manufacturing facility.
",

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