Sr.Executive/Asst.Manager -Sterile API (MLT & BET Expertise)

Role & responsibilities

• Lead the sterile API production operations

  , ensuring all activities align with production schedules and adhere to GMP requirements.
• Ensure the proper execution of

  Microbial Limit Tests (MLT)

  and

  Bacterial Endotoxin Tests (BET)

  as part of in-process control and finished product release.
• Provide technical leadership and troubleshoot any challenges during production to ensure

  sterile conditions

  are maintained throughout manufacturing.
• Implement and manage

  sterilization processes

  , including the use of

  autoclaves

  and other sterilization equipment, ensuring all systems are validated and functioning optimally.
• Oversee the execution and analysis of

  environmental monitoring

  for contamination control and

  cleanroom maintenance

  .

• Review and approve SOPs, batch records

  , and technical documentation for sterile operations and testing.
• Collaborate with

  Quality Assurance (QA)

  and

  Quality Control (QC)

  teams to resolve any deviations, CAPAs, or issues related to

  sterility or endotoxin failures

  .
• Maintain continuous

  training programs

  for the production team on

  MLT/BET protocols

  , regulatory updates, and aseptic techniques.
• Act as a subject matter expert and provide guidance to cross-functional teams on sterile manufacturing practices and testing requirements.
• Continuously evaluate and improve production efficiencies through lean manufacturing principles and process optimization.
• Manage compliance with

  regulatory standards

  (FDA, EMA, WHO, etc.), ensuring full inspection readiness and the ability to address regulatory concerns effectively.

Skills & Competencies:

• In-depth experience in

  sterile API manufacturing

  and understanding of

  aseptic processing

  and

  cleanroom management

  .
• Strong knowledge and hands-on experience with

  MLT (Microbial Limit Testing)

  and

  BET (Bacterial Endotoxin Testing)

  .
• Deep understanding of

  GMP, GLP

  , and regulatory guidelines governing pharmaceutical manufacturing.
• Experience in

  troubleshooting and resolving production issues

  related to sterility and endotoxin contamination.
• Leadership experience in managing production teams and cross-departmental collaboration.
• Proven track record in

  process optimization

  and driving continuous improvement initiatives.
• Strong ability to mentor and develop talent within the production department.

Preferred Experience:

• Significant experience in

  leading sterile production operations

  for complex formulations or highly regulated products.
• Exposure to

  multi-site production

  and managing scale-up processes for sterile manufacturing.
• Expertise in

  regulatory inspections

  and

  quality audits

  (FDA, EMA, etc.).
• The Senior will oversee and manage the production processes within the

  sterile API manufacturing facility,

  ensuring optimal operations while maintaining a high standard of quality and compliance with regulatory standards. The role requires extensive knowledge in

  Microbial Limit Testing (MLT)

  ,

  Bacterial Endotoxin Testing (BET)

  , and comprehensive experience in

  sterile process management

  . This person will lead production teams, drive process improvements, and ensure that all operations are carried out in accordance with GMP, SOPs, and international regulations.

Why Join Us?

• Opportunity to lead in a state-of-the-art

  sterile API facility

  with cutting-edge technology.
• Competitive salary and benefits.
• Be part of a collaborative, quality-driven team focused on delivering life-changing medicines globally.