Production Junior Associate , Associate ,Senior Associate – Drug Substance

Biocon Sdn Bhd; Iskandar Puteri; On-site; MYR 54,000 - 76,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Insurance coverage for you and family

Annual and casual leave

Duty meals provided

In-house gym/sports room

Career advancement opportunities

Job summary

Biocon Sdn Bhd in Malaysia seeks a Production Junior Associate to support drug substance manufacturing in a cGMP environment. You will execute production operations, maintain batch records, ensure data integrity, and assist in audits while coordinating training and CAPA activities.

Ideal candidates have 1–6 years in pharma manufacturing, strong documentation skills, and the ability to work in a regulated setting. Biocon offers competitive benefits and growth opportunities.

Qualifications

• Bachelor’s Degree in Biotechnology, Chemical Engineering, Bioprocess Engineering, Biochemistry or equivalent field.
• 1–6 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing.
• Knowledge of cGMP, GDP, Data Integrity, and pharmaceutical manufacturing practices.
• Understanding of ALCOA principles and documentation compliance.
• Strong communication and coordination skills.
• Problem-solving and investigation handling capabilities.
• Ability to work in a regulated manufacturing environment.
• Familiarity with deviations, CAPA, OOS, and OOT management.
• Good documentation and reporting skills.

Responsibilities

• Execute production operations in compliance with cGMP, GDP, DI and EHS requirements.
• Update BMRs and production documents in real time.
• Provide guidance to ensure Data Integrity and GDP compliance.
• Coordinate with Engineering for maintenance of premises and equipment.
• Support and handle internal and external audits and CAPA implementation.
• Prepare, review and revise SOPs and training records.

Skills

cGMP knowledge

GDP knowledge

Data Integrity

ALCOA

Documentation

Interpersonal skills

Problem-solving

Education

Biotechnology

Chemical Engineering

Bioprocess Engineering

Biochemistry

Job description

Production Junior Associate , Associate ,Senior Associate – Drug Substance

Responsible for executing production operations in compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), Data Integrity (DI), and Environmental Health & Safety (EHS) requirements. Ensure accurate documentation, smooth batch execution, compliance monitoring, training coordination, and audit support within the manufacturing plant.

Key Responsibilities:

Gain knowledge and understanding of applicable GxP requirements based on job profile, including cGMP, GDP, Data Integrity, GLP and other relevant trainings.

Provide guidance and recommendations to ensure compliance with Data Integrity (DI) and Good Documentation Practices (GDP).

Ensure all documentation is accurate, timely, legible, complete, and permanent in accordance with ALCOA principles.

Execute production process operations and monitor batch performance as per approved standard operating procedures (SOPs).

Ensure compliance with current Good Manufacturing Practices (cGMP) during all manufacturing activities.

Execute instructions related to production operations effectively and efficiently.

Adhere to Environmental Health & Safety (EHS) policies and procedures at all times.

Update Batch Manufacturing Records (BMRs) and other production documents in real time.

Ensure proper maintenance and utilization of raw materials as per production requirements.

Report, evaluate, investigate, and close deviations, CAPA, OOS, and OOT within defined timelines.

Ensure implementation and effectiveness of Corrective and Preventive Actions (CAPA) within the plant.

Coordinate with the Engineering department for timely maintenance of production premises and equipment.

Communicate and elevate process and facility related issues to higher management in a timely manner

Prepare, review, and revise SOPs, records, and other required documentation as necessary.

Implement and maintain GDP practices in accordance with ALCOA principles.

Conduct employee training programs and ensure all training records are maintained and updated.

Support and handle internal and external audits, ensuring audit readiness and compliance.

Bachelor’s Degree in Biotechnology, Chemical Engineering, Bioprocess Engineering, Biochemistry or equivalent field.

1 - 6 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations

Knowledge of cGMP, GDP, Data Integrity, and pharmaceutical manufacturing practices

Understanding of ALCOA principles and documentation compliance

Strong communication and coordination skills

Problem-solving and investigation handling capabilities

Ability to work in a regulated manufacturing environment

Familiarity with deviations, CAPA, OOS, and OOT management

Good documentation and reporting skills

AboutTheBenefits

AtBiocon,you’llreceiveacompetitivesalaryandarobustbenefitspackage—medical,dental,andinsurancecoveragethatextendstoyouandyourfamily.Enjoyannualandcasualleave,complimentarydutymeals,accesstoanin-housegym/sportsroom,andexceptionalopportunitiesforcareeradvancement.

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.

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.