Assistant Manager, Compliance (Site Investigation Team)

Biocon Sdn Bhd; Gelang Patah; On-site; MYR 120,000 - 180,000; Full time

Job summary

Biocon Sdn Bhd in Malaysia invites applications for an Assistant Manager, Compliance (Site Investigation Team). You will lead investigations for deviations, OOS/OOT, microbial excursions, and non-conformances within a GMP setting, ensuring regulatory compliance and CAPA effectiveness.

You will review reports for data integrity, support audits, and drive timely closure of quality events while collaborating with cross-functional teams.

Qualifications

• Bachelor's degree in Biotechnology, Chemical Engineering or related field.

Responsibilities

• Lead and support investigations for deviations, OOS, OOT, microbial excursions, and non-conformances in a GMP environment.
• Review investigation reports with a focus on data integrity and regulatory compliance (GMP, GDP, ALCOA).
• Coordinate audits and CAPA activities, ensuring timely closure of quality events.
• Contribute to QMS activities and training programs using TrackWise or similar systems.

Education

Bachelor's degree in Biotechnology or Chemical Engineering or related field

Job description

Assistant Manager, Compliance (Site Investigation Team)

Responsible for managing and supporting site investigations related to deviations, OOS (Out of Specification), OOT (Out of Trend), microbial excursions, and manufacturing non-conformances within a GMP-regulated environment.

Key responsibilities

Lead and support investigations for deviations, OOS, OOT, and market complaints using structured root cause analysis methodologies

Conduct microbial investigations, impact assessments, and CAPA implementation to ensure regulatory compliance and prevent recurrence

Collaborate with cross-functional teams to drive timely closure of quality events and achieve effective investigation outcomes

Review investigation reports, assess data integrity, and ensure compliance with GMP, GDP, and ALCOA principles

Perform trend analysis of quality events and provide recommendations for continuous improvement

Support internal and external audits, including audit responses and compliance readiness activities

Manage investigation tracking, documentation control, and QMS activities through TrackWise and other quality systems

Coordinate department training programs, SAP SuccessFactors learning management activities, and employee qualification compliance

Act as a reviewer and technical resource for investigation strategies, risk assessments, and quality decision-making processes

About you

Minimum Bachelor's Degree in Biotechnology, Chemical Engineering, or any Engineering-related field

Your application will include the following questions:

• Which of the following statements best describes your right to work in Malaysia?
• Which of the following types of qualifications do you have?

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

In 2012, with more than 40 years of success behind it, 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.

The attached document speaks about the journey and the many challenges and milestones encountered along the way. It talks of the Human Capital strategy of the company and how the Malaysia story is embedded in the same.

There were several steps which led to the success and many of them were differentiated with innovative ideas and sharp business acumen.

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!

In 2012, with more than 40 years of success behind it, 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.

The attached document speaks about the journey and the many challenges and milestones encountered along the way. It talks of the Human Capital strategy of the company and how the Malaysia story is embedded in the same.

There were several steps which led to the success and many of them were differentiated with innovative ideas and sharp business acumen.

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).