GMP & Quality Assurance Lead – Downstream Biopharma

Biocon; Johor Bahru; On-site; MYR 180,000 - 260,000; Full time

Job summary

Biocon Biologics, a subsidiary of Biocon Ltd, seeks a senior professional with 10+ years in Pharma to lead quality and compliance in GMP-regulated environments. You will handle cGMP, GDP, data integrity, QMS, and equipment qualification, while ensuring accurate documentation and cross-functional collaboration.

Role emphasizes cGMP training, ALCOA documentation, and adherence to EHS policies, with focus on PDS-Downstream processes and continuous improvement across QA activities.

Qualifications

• Bachelor's or Master's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or related disciplines with 10+ years of experience in Pharma background
• Experience in biopharmaceutical manufacturing, downstream processing, purification operations, or GMP-regulated environments
• Strong knowledge of cGMP, GDP, Data Integrity, Quality Management Systems (QMS), and equipment qualification
• Good documentation, troubleshooting, and interpersonal skills
• Ability to work in a cross-functional manufacturing environment

Responsibilities

• Gain knowledge on the subject for an employee based on his/her job profile such as basics of cGMP, GDP, Data Integrity, GLP, Microbiology, or any other GxP Training
• Employee involved in GMP activities should undergo mandatory cGMP Training
• Frequency of mandatory training is once in a year
• All employees that involve with GxP environment should undergo a mandatory basic microbiology training
• Provide information guidance and recommendations to facilitate compliance with DI, GDP in documentation
• Ensure that all documentation is accurate, timely, legible, complete and permanent (ALCOA principle)
• Monitor the compliance with the requirements of Good Manufacturing Practice
• Ensure that the instructions relating to production operations are strictly followed
• Update real time data entry in BMR's, CKL, LS, ECC and other documents
• Ensure products are produced and stored according to documentation to obtain required quality
• Ensure that all production deviation are reported and evaluated and that critical deviations are investigated and conclusions recorded
• Check maintenance of PDS-Downstream premises and equipment
• Ensure timely and effective communication and escalation process exists and raise quality issues to appropriate levels
• Ensure continued training of PDS-Downstream personnel is carried out and adapted
• Prepare / review SOP, EOP, Checklists, Log Sheets and related documents
• Ensure availability of updated training records for employees
• Comply with EHS policies and procedures
• Responsible for OTIF execution of all activities related to PDS-Downstream Purification-1
• Prepare / review protocols for Re-Qualification (RQ) and Periodic Qualification review (PQR)
• Execute requalification of equipment and closure of reports
• Close all QMS related activities related to qualification
• Data owner for process equipment used in day-to-day activity

Skills

cGMP knowledge

GDP knowledge

Data Integrity

QMS knowledge

Equipment qualification

Documentation skills

Interpersonal skills

Cross-functional collaboration

Education

Biotechnology / Biochemistry / Chemical Engineering / Life Sciences (Bachelor's or Master's)

Job description

Biocon Biologics, a subsidiary of Biocon Ltd, seeks a senior professional with 10+ years in Pharma to lead quality and compliance in GMP-regulated environments. You will handle cGMP, GDP, data integrity, QMS, and equipment qualification, while ensuring accurate documentation and cross-functional collaboration.

Role emphasizes cGMP training, ALCOA documentation, and adherence to EHS policies, with focus on PDS-Downstream processes and continuous improvement across QA activities.