Deputy Manager - Drug Substance Insulin

Biocon; Johor Bahru; On-site; MYR 180,000 - 300,000; Full time

Job summary

Biocon Biologics, a leading biopharmaceuticals company, seeks a senior professional with 10+ years in pharma to uphold cGMP/GDP standards across downstream manufacturing. You will ensure data integrity, maintain QA/QMS processes, and drive compliant documentation and training.

The role emphasizes ALCOA documentation, deviation management, and cross-functional collaboration to sustain product quality and regulatory readiness in a GMP environment.

Qualifications

• 10+ years of pharma experience, preferably in biopharmaceutical manufacturing.
• Experience in downstream processing and GMP environments.
• Strong knowledge of cGMP, GDP, Data Integrity, QMS, and equipment qualification.
• Good documentation, troubleshooting, and interpersonal skills.

Responsibilities

• Gain knowledge on basics of cGMP, GDP, Data Integrity, GLP and other GxP training.
• Undergo mandatory cGMP training annually.
• Provide guidance to facilitate compliance with DI and GDP in documentation.
• Ensure ALCOA-compliant documentation.
• Monitor compliance with GMP requirements.
• Ensure production instructions are followed.
• Update real-time data entries in BMRs and related docs.
• Ensure proper storage/production per documentation for quality.
• Report and evaluate deviations; investigate critical ones.
• Maintain PDS-Downstream premises and equipment.
• Maintain training records for PDS-Downstream personnel.
• Comply with EHS policies.

Skills

cGMP knowledge

GDP knowledge

Data Integrity

QMS knowledge

Documentation

Education

Bachelor's or Master's in Biotechnology/Life Sciences

Job description

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated pure play biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.

https://www.bioconbiologics.com

Key roles and responsibilities

• To gain knowledge on the subject for an employee 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)
• 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.
• To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality.
• To ensure that all production deviation are reported and evaluated and that critical deviations are investigated and the conclusions are recorded.
• To check the maintenance of PDS-Downstream premises and equipment.
• To ensure that a timely and effective communication and escalation process exists and raise quality issues to the appropriate levels.
• To ensure that the required initial and continuing training of PDS-Downstream personnel is carried out and adapted according to need.
• Preparation of SOP, EOP, Checklists, Log Sheets and related documents.
• To ensure the availability of updated training records for employees.
• To comply with EHS policies and procedures.
• Responsible for OTIF execution of all activities related to PDS-Downstream Purification-1.
• To prepare / review the protocols for Re-Qualification (RQ) and Periodic Qualification review (PQR).
• To execute the requalification of equipment and closure of reports.
• Closure of all QMS related activities related to qualification.
• Data owner for process equipment used in day-to-day activity.

Preferred 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.