Qc Microbiologist

The Quality Control Microbiology Lead is responsible for providing leadership support within the QC Microbiology department. You will be responsible for oversight of the routine testing including utilities, product testing, environmental monitoring, scheduling, and ensuring testing is completed. You will also be required to perform routine tasks such as reviewing and approving standard operating procedures (SOPs), test methods and Process Performance Qualification Protocols. Must have effective interpersonal skills to solve problems with cross-functional team members.

**Responsibilities**:
Responsible for routine microbiological quality control testing of all finished, in-process, and raw material samples; testing includes bioburden, endotoxin and sterility testing.

Prepare and maintain quality records for review of completeness and accuracy to meet company expectations including Certificates of Analysis and Certificate of Testing

Collaborates with other departments or cross-functioning to meet company goals and/or timelines.

Assures testing is completed and approved within required timeframes in a cGMP compliant manner.

Coordinates environmental monitoring and testing with manufacturing and validation departments.

Maintain documentation for testing, including logbooks and test records

Responsible for lab inventory; waste, lab assets and sample management

Takes responsibility and accountability for individual actions that could affect the team goal

Responsible for hiring, training, providing guidance and managing a team of direct reports.

Assures all practices and procedures are carried out in compliance with required standards conformed to Nexus Pharmaceuticals, cGMP, SOPs, internal requirements and regulatory regulations and guidelines

Reviews and approves controlled documents including but not limited to SOPs, Test Methods, Stability Protocols and Specifications, Process Performance Qualification Protocols and registration batches

Support internal and external documents such as Out of Specification (OOS) investigations, Deviations, CAPAs, and Quality Protocols, as necessary

Conduct and review laboratory investigations, EM trending, identifying deviations and out of specifications

Lead the identification and implementation of improvement opportunities within department and set proactive measure to prevent issues

Perform testing as needed, the testing includes bioburden, endotoxin and sterility testing

Performs other functions as required or assigned

**Requirements**:
Skills and Abilities:
A comprehensive understanding of USP, FDA, and ICH requirements guidelines and procedures

Demonstrates the ability to multi-task, manage multiple projects at one time, and rapidly change priorities based on business needs. Extremely strong organizational, project management, communication, analytical, Excel, and customer services skills

Strong communication skills, both written and verbal

Education or Experience:
BS, MS, or Doctoral degree in Microbiology or related field(s)

Previous experience supervising individuals

**Job Types**: Full-time, Permanent

Pay: ₹8,220.94 - ₹65,918.98 per month

Schedule:

- Morning shift

**Experience**:

- total work: 8 years (preferred)

Ability to Commute:

- Chandigarh, Chandigarh (required)

Ability to Relocate:

- Chandigarh, Chandigarh: Relocate before starting work (required)

Work Location: In person

**Speak with the employer**
+91 7696499529