Assistant Manager – Manufacturing QA / Process & QMS

Biocon Sdn Bhd; Johor Bahru; On-site; MYR 180,000 - 240,000; Full time

Job summary

Biocon Sdn Bhd in Malaysia seeks an Assistant Manager to lead Manufacturing QA, focusing on process validation and Drug Substance operations. You will oversee upstream/fermentation and downstream purification, ensuring compliance with QA standards and regulatory expectations.

The role involves reviewing batch records, deviations, investigations, CAPAs and change controls, supporting batch disposition, and driving QMS improvements.

Qualifications

• 6–10 years in Biopharma Manufacturing QA
• Preferably Drug Substance operations
• Experience with deviations, investigations and change controls

Responsibilities

• QA oversight of process validation and Drug Substance manufacturing.
• Oversee upstream/fermentation and downstream/purification processes.
• Review batch records, deviations, investigations, CAPAs and change controls.
• Support batch disposition and manufacturing QMS.
• Assist audit/inspection readiness and quality improvement activities.

Skills

QA oversight

Process validation

Batch records

CAPA & deviations

Job description

Assistant Manager – Manufacturing QA / Process & QMS

Assistant Manager – Manufacturing QA / Process & QMS

Key Responsibilities:

QA oversight of process validation and Drug Substance manufacturing.

Oversight of upstream/fermentation and downstream/purification processes.

Review of batch records, deviations, investigations, CAPAs and change controls.

Support batch disposition and manufacturing QMS.

Support audit/inspection readiness and quality improvement activities.

Experience: 6–10 years in Biopharma Manufacturing QA, preferably Drug Substance operations.

Your application will include the following questions:

• 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!

What can I earn as a Manufacturing Manager