Senior Executive, QMS (Specialize in QMS)

Biocon Sdn Bhd; Gelang Patah; On-site; MYR 78,000 - 123,000; Full time

Job summary

Biocon Sdn Bhd in Johor Bahru seeks a Senior Executive, QMS to ensure EHS compliance in the QC Analytical Laboratory and apply Good Documentation Practice for traceability and audit readiness.

You will lead deviations, OOS/OOT, CAPA, and audit activities, maintain lab compliance, manage waste disposal, and drive QMS metrics and improvements across QC Analytical operations.

Qualifications

• Experience in quality management systems
• Good documentation practices in lab settings
• Familiarity with cGMP and regulatory expectations

Responsibilities

• Ensure adherence to EHS compliance at QC Analytical Laboratory.
• Ensure GDP is in place and recorded for traceability and audit readiness.
• Maintain housekeeping and cleanliness in QC Analytical department.
• Prepare and continuously improve SOPs, EOPs, and Specifications per cGMP revisions.
• Ensure safe and compliant disposal of laboratory waste per regulations.
• Maintain laboratory facilities and equipment per recommended standards.
• Participate in QMS metric setting and KPI monitoring for the QMS team.
• Manage QMS elements (Deviation, OOS, OOT, CAPA, CC, CAPAEM) including investigations and closures.
• Conduct investigations of Deviations, OOS & OOT and coordinate with QA for closure.
• Handle Lab Incident investigations and maintain the incident register and reports.
• Assist in Product Complaint investigations with QA coordination.
• Oversee internal and external audits and identify compliance risks and improvement areas.
• Facilitate internal/external audits in Quality Control Analytical.
• Lead internal laboratory compliance investigations across functions in QCA.
• Prepare revisions and change controls for relevant documents.

Skills

QMS management

GDP awareness

EHS compliance

Audit coordination

Job description

Senior Executive, QMS (Specialize in QMS)

Ensure adherence to EHS compliance at QC Analytical Laboratory.

Ensure Good Documentation Practise (GDP) is in place and applied in recording of QC daily activities for easy traceability and facilitate audit requirement.

Ensure the proper housekeeping and cleanliness is maintained in QC Analytical department.

Preparation and continuous improvement of all relevant SOPs, EOPs, Specifications and ensure those procedures are revised and updated in accordance to stipulated interval and as per cGMP requirement / latest pharmacopoeia revisions.

Ensure proper safe and regular disposal of laboratory waste such as solvent, reagents and etc. following the requirements of EHS Department and local regulations.

Ensure the laboratory facilities and equipment are well maintained as per recommended requirement.

Involve in Quality Management System activity of setting and monitoring metrics of performance and KPI’s of the QMS team in QCA.

Handling of all QMS elements (Deviation, OOS, OOT, CAPA, CC, CAPAEM) by ensuring the raising, handling, investigations, submissions and closures and perform accordingly for QCA department.

Perform and review investigations of Deviations, OOS & OOT raised by QCA personnel and coordinate with QA for the closure.

Handling of Lab Incident investigation and ensuring proper closure of the lab incident.

Manage and monitor Laboratory Incident register and report.

Handling of Product Complaint and assist in the investigation and coordination with QA.

Oversees laboratory compliance self-assessments, coordinates laboratory audits, and identifies compliance risks and issues. Benchmarks and shares best compliance practices in the laboratory area.

Facilitate an internal / external audit in Quality Control Analytical.

Manages and conduct internal laboratory compliance investigations for across the functions in QCA department.

Responsible for preparation for any revision and new of relevant document and issuance of change control form and deviation.

Biocon, India's largest biotech company set up their first overseas plant in Johor Bahru, Malaysia – Asia’s largest integrated Insulin manufacturing facility. With an investment of about USD 275 million, it is the highest foreign investment in Malaysia’s biotech sector till date and currently employs about 650 professionals in a state-of-the-art facility.

Biocon Malaysia offers an excellent career opportunity for biotech professionals.

If you want to be a part of a Company that constantly creates history and consistently earns more accollades for its innovations and other significant accomplishments and contributions, then we invite you to be a part of the BIOCON FAMILY!

Registration No. 201101002193 (930330-U).

Pharmaceuticals, Biotechnology & Medical Devices 101-1,000 employees

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