Deputy General Manager/ General Manager - Microbiology

Role & responsibilities

1. Responsible for overall activities of the Microbiology department in timely release of stan materials, In-process and Finished Products w.r.t the Microbiological testing.
2. Responsible for Microbiological monitoring of Aseptic processing area, auxiliary areas manufacturing as per the scheduled requirements.
3. Accountable for the compliance and Analytical Assurance in Microbiology department on to-day activities.
4. Responsible for day-to-day activities of the Microbiology department by balancing the resources and workload to achieve the management goals and completion of allotted tasks.
5. Co-ordination with Process and Product testing team managers and team leaders for smooth operations in according to the priorities, routine monitoring of work progress and completion assigned jobs.
6. Training to the Microbiologists and Aseptic processing operators on current aspects of regulatory requirements and on Pharmacopoeia / compendial updates.
7. Responsible to notify the senior management about the potential quality or regulatory issues may impact the product quality or the regulatory compliance.
8. Data trend analysis for the Microbiological tests, risk assessment and recommending opportunities for improvement.
9. Ensuring cGMP and cGLP maintenance in the Microbiology laboratory.
10. Ensuring the compliance in Microbiology method validations for the Finished products, starting materials and other Miscellaneous method validations.
11. Investigations in case of Out of limits, Out of Trends, Out of Specifications, Media fill fail or any other discrepancies that impact the Microbiological quality of the Product.
    Review of Standard Operating procedures, Standard Test procedures to be followed in Microbiological testing.
12. Review of Process validation, Cleaning Validation & Media fill validation protocols reports.
    Associated in control of Microbial contamination of the aseptic process areas and ensuring Sterility assurance of the products manufactured by the site.

Preferred candidate profile

• Masters degree in Microbiology, Biotechnology, Life Sciences with 16+ years of experience in microbiology within pharmaceutical manufacturing
• Extensive hands-on and leadership experience in

  sterile injectable / aseptic manufacturing

• Proven experience supporting and leading global regulatory inspections (US FDA, EU GMP, etc.)
• Strong knowledge of sterile microbiology and aseptic processing
• Hands-on experience with EM, sterility testing, and endotoxin testing
• Familiarity with regulatory expectations and audit handling
• Leadership, problem-solving, and investigation skills
• Strong documentation and communication skills
• Ability to work cross-functionally with QA, Production, and Engineering