Shift Production Lead - GMP Compliance & Ops

Biocon

Gelang Patah

On-site

MYR 56,000 - 89,000

Full time

14 days+

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Benefits offered by this job

Shift allowance

Job summary

Biocon in Malaysia (Gelang Patah) is seeking a Shift Lead for Downstream-Buffer operations. You will act as the first responder to production issues, supervise the shift, ensure GMP compliance, and maintain accurate batch records and data entries.

The role requires 1–3 years of relevant experience and a Bachelor's degree in Chemical/Bioprocess/Biology or related sciences. You will coordinate maintenance with Engineering, support EHS safety practices, handle deviations (OOS/OOT), and contribute

Qualifications

Bachelor's degree in Chemical/Bioprocess/Biology or science-related field.
1-3 years of experience.
Shift requirement: Yes, 3 rotational shifts with shift allowance.
Preferred industry: manufacturing/production.

Responsibilities

Be the shift in charge and act as first responder to production issues.
Supervise the shift; review batch records, logbooks and other records; guide shift personnel to GMP.
Monitor area and documentation for GMP compliance.
Ensure availability and real-time data entry in Batch Manufacturing Records, Checklists, Log Sheets and Equipment Cleaning Checklist.
Prepare and execute equipment qualification and validation protocols for Buffer.
Comply with EHS policies; ensure safety practices by all shift personnel and contractors.
Report, evaluate and investigate production deviations, OOS or OOT.
Plan and coordinate maintenance and calibration of buffer equipment with Engineering and Instrumentation teams.
Ensure OTIF execution of all Downstream-Buffer activities.
Assist with planning production schedule for unit operations.
Data owner for process equipment used in day-to-day activity.