ASSOCIATE - DRUG SUBSTANCE PRODUCTION

Biocon Sdn Bhd; Johor Bahru; On-site; MYR 67,000 - 100,000; Full time

Job summary

Biocon Sdn Bhd in Malaysia seeks a biotech/pharma professional to monitor GMP compliance and ensure production instructions are followed. The role involves updating real-time data entries in BMRs and related documents and supporting qualification activities.

The successful candidate will hold a Bachelor's degree in biotechnology or chemical engineering, with 1–4 years of hands-on experience in Drug Substance manufacturing or similar operations, and participate in mandatory cGMP training annually.

Qualifications

• 1-4 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations.
• Must be familiar with cGMP, GDP, DI, GLP and training requirements.

Responsibilities

• Monitor compliance with Good Manufacturing Practice (GMP).
• Ensure production instructions are followed.
• Update real-time data entries in DSP2 (BMRs, CKL, LS, ECC).
• Execute equipment qualification and validation protocols.
• Maintain production equipment in coordination with maintenance.
• Comply with EHS policies and procedures.
• Responsible for OTIF execution of Downstream Purification-2 activities.
• Data owner for process equipment.

Skills

GxP training

cGMP knowledge

Data integrity

Documentation

Education

Bachelor's degree in biotechnology or chemical engineering

Job description

To monitor the compliance with the requirements of Good Manufacturing Practice

To ensure the instructions relating to production operations are strictly followed

To update the real time data entry in BMR'S,CKL, LS, ECC and other documents in DSP2

To execute equipment qualification protocols and validation protocols.

To perform and document operations in accordance with cGMP.

Maintenance of Production equipment in co-ordination with maintenance department

To comply with EHS policies and procedures

Responsible for OTIF execution of all the activities related to Downstream Purification-2

Data owner for process equipment used in day-to day activity

To gain knowledge on the subject for an employe e based on his/her job profile such as (not limited to) Basics of cGMP, GDP, Data Integrity, GLP, Microbiology, or any other GxP Training, as applicable.

Employee who are involved in GMP activities should undergo mandatory cGMP Training.

Frequency of mandatory training is once in a year.

All employees that involving with GxP environment should undergo a mandatory basic microbiology training.

To provides information guidance and recommendations to facilitate compliance with DI, GDP in documentation.

To ensure that all documentation is accurate, timely, legible, complete and permanent (ALCOA principle).

Bachelor's degree in biotechnology, Chemical Engineering, or equivalent field.

1 - 4 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations

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.

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).