Full-timeHealthcare & care· Posted 28 Sept

Batch Release Lead

SanofiFrom company site

Salary

Not stated by the company

When

Full-time hours

Where

Singapore

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Start: Not stated
Work mode: On-site
Experience: Experienced

About the role

This role provides Quality Assurance oversight for final drug substance disposition, batch release, deviation management, change control and Product Quality Review at a pharmaceutical site. You will work closely with Manufacturing, Quality, Regulatory and other site stakeholders to ensure products are assessed and dispositioned according to Good Manufacturing Practices and regulatory standards. It suits an experienced QA professional who is detail-oriented and comfortable in a dynamic environment.

What you'll do

Perform final drug substance disposition for release to secondary customers.
Review batch-related quality information and confirm all requirements are completed before disposition.
Investigate and resolve issues or deviations affecting batch release.
Ensure batch release and disposition activities comply with GMP and quality requirements.

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Take part in Quality Alert/Product Alert meetings so investigations and actions support lot disposition decisions.

Act as QA reviewer for site deviations, ensuring investigations are thorough, scientifically sound and timely.

Lead or support root cause analysis for quality incidents and identify corrective and preventive measures.

Review investigation outcomes and assess impact on product quality and batch disposition.

Serve as operational Quality contact for complaint investigations needing site support, including coordinating reports.

Review, assess and approve site change controls, evaluating quality and regulatory impacts.

Perform Product Quality Reviews in line with site and regulatory requirements.

Collaborate with the Regulatory Support Officer on local and international regulatory compliance.

Ensure activities follow GMP, site procedures and Quality Assurance principles.

Identify and implement continuous improvement initiatives for deviation investigation processes and monitoring.

Review performance metrics and trends to find improvement opportunities.

Support improvements to Quality systems and operational processes while maintaining compliance.

Participate in internal and external audits and regulatory inspections.

Support inspection readiness and provide Quality documentation and subject matter support.

Support follow-up and closure of observations and related actions.

Good to know

Location: City of Singapore.
Full time role.

Requirements

At least 5 years of Quality Assurance experience in the pharmaceutical industry
Strong focus on deviation management and batch release/disposition processes
Strong knowledge and practical understanding of Good Manufacturing Practices (GMP) and Quality Assurance principles
Experience supporting quality investigations, change controls and other pharmaceutical Quality systems
Strong capability to investigate, assess and resolve quality issues or deviations efficiently
Good analytical and problem-solving skills, including root cause analysis experience

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Batch Release Lead

About the role

What you'll do

Good to know

Requirements

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