Microbiology Manager

Job Description:

We are seeking an experienced and visionary Microbiology Manager to lead Evertogen Pharma's microbiology initiatives. This role involves overseeing microbiological analysis in finished dosage forms, driving innovation, ensuring regulatory compliance, maintaining data integrity, and conducting antibiotic assays. The candidate should have over 8 yearsof industry experience, an M.Sc in Microbiology, and a proven track record in relevant roles within the pharmaceutical sector. At Evertogen, you will play a pivotal role in the company's success while enjoying personal and professional growth within a dynamic and supportive environment. Apply now to be part of our forward-thinking team!

Job Details:

• Industry: Pharmaceuticals Finished Dosage Forms Manufacturing
• Department: Quality Control
• Role: Manager Microbiology
• Location: Jadcherla, Mahboobnagar
• Compensation: 8 - 10 LPA
• Experience: 8 to 11 Years
• Qualification: M.Sc in Chemistry

Responsibilities:

Microbiology Laboratory Management and Operations

1. Oversee daily operations and manage laboratory equipment.
2. Manage consumables, inventory, and ensure personnel follow SOPs.
3. Maintain accurate records, plan lab activities, and troubleshoot issues.
4. Drive continuous improvement initiatives and maintain cleanliness.
5. Adhere to safety procedures and maintain overall laboratory standards.

Environmental Monitoring and Control

1. Lead the environmental monitoring program and conduct routine sampling.
2. Develop and implement plans, analyze trends, and generate reports.
3. Initiate corrective actions and maintain detailed logs.
4. Calibrate equipment, ensure accurate documentation, and oversee contamination control.

Water Testing and Analysis

1. Manage the water testing program and conduct routine tests.
2. Ensure compliance with regulatory standards and maintain accurate records.
3. Calibrate equipment, manage maintenance, and identify deviations.
4. Ensure complete documentation and analyze test results.

Microbial Strain Management and Identification

1. Manage the collection, storage, and traceability of microbial strains.
2. Oversee microorganism identification and maintain a comprehensive database.
3. Develop procedures for safe handling and disposal of cultures.
4. Ensure the integrity and periodic review of the culture collection.

Method Validation and SOP Development

1. Lead development and validation of testing methods.
2. Create, review, and update SOPs, ensuring compliance with regulations.
3. Train personnel, ensure clear documentation, and align with GMP guidelines.

Antibiotic Assays

1. Conduct and validate antibiotic potency assays.
2. Train team members, maintain accurate records, and prepare detailed reports.
3. Monitor procedures for improvements and accuracy.

Audit and Regulatory Compliance

1. Prepare the lab for internal and external audits and maintain records.
2. Ensure adherence to cGMP guidelines and address audit findings.
3. Implement CAPA and keep up-to-date with regulations.

Data Integrity and Documentation

1. Ensure data integrity and implement robust management systems.
2. Train personnel in good documentation practices and investigate deviations.
3. Participate in data review and identify trends.

Team Leadership and Development

1. Lead and manage a team of microbiologists and technicians.
2. Provide guidance, training, and set performance goals.
3. Foster a positive work environment and conduct performance reviews.
4. Identify training needs and implement development programs.

General Expectations of Skills and Past Experience

1. Proven expertise in microbiology testing and equipment operation.
2. Strong emphasis on data integrity and documentation practices.
3. In-depth knowledge of pharmaceutical cGMP regulations and audit preparation.
4. Leadership and team management experience.
5. Ability to identify and resolve laboratory issues.
6. Capacity to implement effective data management systems.
7. Commitment to regulatory compliance and accurate record-keeping.