Title:  QC Micro

Position:

QC Micro

Job Title:

QC Micro

Job Grade:

(G9B - Senior Manager 2)

Function:

QA / QC

Sub-function:

Manager’s Job Title:

Skip Level Manager’s Title:

Function Head Title:

Location:

Central or South India (Greenfield Project)

No. of Direct Reports (if any)

3 to 4

Job Summary

QC lead's responsibilities encompass ensuring quality standards, leading the QC team, managing processes, and improving quality control measures, including developing and implementing quality control systems and protocols, and training and supervising staff. 

Areas of Responsibility

1. Procurement and qualification of environmental monitoring system like viable and non-viable monitoring system
2. Involved during designing parts with respect to the environmental and microbial sampling new process equipment’s and area.
3. To prepare and execution of qualification protocol like URS, DQ, IQ, OQ, PQ and schedule PVPTS protocol.     
4. Planning and monitoring of environmental monitoring within facility.

Oversight of the aseptic operations, environmental monitoring activity – for viable particle count (VPC) and Non-Viable particle count (NVPC).

Evaluation and interpretation of environmental monitoring VPC, NVPC and utility   monitoring (nitrogen gas, compressed air, CO2 gas) results.

To review trend for viable and non-viable monitoring data and suggest action if any.

To review trend of microbiological monitoring of personnel of aseptic area. To participate in the aseptic process risk assessment.

To participate in evaluating the sampling locations for environmental monitoring   based on risk assessment and critical interventions.

Planning and monitoring to maintain all environmental monitoring related all systems

5. To review smoke study protocol and executed videos.

Ensure the computerized systems validated in compliance with the quality policies, standards and procedures and are maintained in validated statue throughout the lifecycle.

6. Planning and monitoring for pharmacopeia changes updating
7. CAPEX approval and annual budgeting.
8. To fulfil the regulatory requirements

      9) Handling of Environmental monitoring (Viable and non-viable) related incident:

1) To review the incident related to aseptic practices.

2)Participate in the microbiological related incidents, investigation and other microbial impact assessment wherever and whenever required.

10) Planning and monitoring to media fill related activities :

Handling of media fill visual inspection activity and media fill video review and summary preparation.

To participate in media fill process. Evaluate the protocol for interventions to be performed and review of media fill related documentation.

To monitor clean room practices during routine production and media fill runs to evaluate and to suggest improvement in practices if required.

Participate in the investigations media fill investigations.

11) Sterility assurance :

Responsible for the Aseptic core monitoring and compilation of sterility assurance review board data.

Conducting the sterility assurance review board and implementing the actions are derived from sterility assurance review board.

Involve implementation of contamination control strategy (CCS) across all the blocks and CCS assessment report review.

12) ACT as system owner and ensure computerized system are validated for its intended use through its lifecycle.

13) Planning and monitoring for training of the analysts and newly joined employee.

14) Planning and monitoring for preparation and reviewing of documents.

15) Timely response to audit compliance.

16) Support the assessment and remediation of identified activities as part of various corporate initiatives.

Travel Estimate

Medium

Job Scope

Internal Interactions (within the organization)

Check in Internal as well as External both

External Interactions (outside the organization)

Check in Internal as well as External both

Geographical Scope

Financial Accountability (cost/revenue with exclusive authority)

Job Requirements

Educational Qualification

Msc. Microbiologist

Specific Certification

Skills

Technical Skills/Competencies (Software packages, experience with specific machines etc.)

Excellent communication skills, strong collaborator, problem solving, interdepartmental coordination, team leadership.

Experience

(12 to 15 Years of experience in relevant field in Pharmaceutical Industry.) Age   35 to 45 Years

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).