Quality Control Analytical - Manager

Biocon; Gelang Patah; On-site; MYR 80,000 - 120,000; Full time

Job summary

A global biopharmaceutical company is seeking individuals for a QC Analytical role in Gelang Patah, Malaysia. Responsibilities include ensuring cGMP compliance, monitoring raw materials, and facilitating audits. The ideal candidate holds a Bachelor’s or Master’s in Chemistry/Biochemistry with 8–12 years of experience in QC, including leadership responsibilities. The company offers a competitive salary, comprehensive medical coverage, and generous leave policies.

Benefits

Competitive salary

Medical, dental, and insurance coverage

Access to in-house gym/sports room

Complimentary duty meals

Qualifications

• 8–12 years’ experience in pharmaceutical / biopharma QC Analytical, including 2–3 years in a lead role.
• In-depth knowledge of cGMP, GDP, QMS, and pharmacopoeial standards.
• Experience with audit facilitation is required.

Responsibilities

• Ensure adherence to cGMP requirements.
• Daily monitoring of Drug Product and Drug Substance incoming raw materials.
• Facilitate an internal / external audit in Quality Control Analytical.

Skills

Leadership

Problem-Solving

Communication

Education

Bachelor’s / Master’s in Chemistry, Biochemistry, Biotechnology, or related field

Tools

LIMS

SAP

Job description

Biocon is a global biopharmaceutical company transforming patients’ lives in over 120 countries. Guided by our vision to deliver affordable, innovative healthcare solutions, we develop treatments for diabetes, cancer, and autoimmune diseases. At Biocon, we value integrity, innovation, and inclusion, fostering a culture that empowers our people to make a meaningful impact on global health.

Key Responsibilities

• Ensure adherence to cGMP requirements.
• Ensure adherence to EHS compliance at QC Analytical Laboratory.
• Ensure Good Documentation Practice is in place and applied in recording of QC daily activities for easy traceability and facilitation of audit requirements.
• 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.
• Ensure proper safe and regular disposal of laboratory waste such as solvent, reagents and etc. following EHS Department and local regulation.
• Daily monitoring of Drug Product and Drug Substance incoming and retest raw materials, Packing Materials and Consumables in SAP system.
• Coordinate and assign activities to team members for routine test analysis and ensure task segregation is well organized to meet timelines.
• Shall co-ordination with other departments to resolve day to day activities with respect to Raw Material, Packing Materials and Water testing as per the specified standards.
• Review of Analytical reports related to Raw materials, packing Materials and Water, Finished product and stability samples.
• Approval/Rejection of Raw Materials, Packing Materials and Water.
• To update Raw Materials and Packaging Material of Drug Product on monthly basis to Global QC.
• 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) 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.
• Liaise and coordinate with other department e.g. Production, QA, Regulatory Sciences, etc. for issue regards to Raw Materials and Packaging Materials.
• Handling of Lab Incident investigation and ensuring proper closure of the lab incident.
• Facilitate an internal / external audit in Quality Control Analytical.
• Responsible for preparation for any revision and new of relevant document and issuance of change control form and deviation.
• Preparation and review of Study protocols.
• SAP and LIMS activities as per designated roles.

Requirements

• Bachelor’s / Master’s in Chemistry, Biochemistry, Biotechnology, or related field.
• 8–12 years’ experience in pharmaceutical / biopharma QC Analytical, including 2–3 years in a lead role.
• In-depth knowledge of cGMP, GDP, QMS, and pharmacopoeial standards.
• Experience with LIMS, SAP, and audit facilitation.
• Strong communication, leadership, and problem-solving skills.

About The Benefits

At Biocon, you’ll receive a competitive salary and a robust benefits package—medical, dental, and insurance coverage that extends to you and your family. Enjoy annual and casual leave, complimentary duty meals, access to an in-house gym/sports room, and exceptional opportunities for career advancement.