Lead - Microbiology

Division

Department

Sub Department 1

Job Purpose

• Overseeing all aspects of Microbiology (Sterile and Non-sterile) at site.
• Responsibility for maintaining & monitoring cGMP Compliance by ensuring applicable systems, processes and procedures are in place.
• Keeps informed of existing and proposed FDA regulation relating to assigned responsibility, appraised their effect on company operation and sees that appropriated action is taken to assure compliance with FDA regulator and compliances for various regulatory agencies.
• Ensuring closure, investigation for investigation of out of specification / out of trend (OOAC &OOAL), complaints, deviation and batch failures (including stability) are appropriately performed and documented, taking appropriate corrective and preventive action based on the results of the investigation.
• To approve all appropriate microbiology related documents pertaining to stability, QMS, Validations e.g procedures, SOPs, layouts, plans, Specifications impacting product quality which include but not limited to Protocols, reports, master document etc, to assure the completeness, consistency and accuracy of cGMP data.
• Collaborate with cross-functional teams including production, stores, engineering, CDC, regulatory affairs, IPD to address microbiology concerns and ensure smooth operations.
• Identification of training needs and imparting training with respect to cGMP, GLP, Safety, Hygiene, application and principles of Quality function.
• Ensure the review of annual product quality report of all drug products and its relevant data / records to assure that products are meeting consistently quality standards.
• To participate in Quality management review.

Key Accountabilities (1/6)

Ensure on time completion/closure of microbiology analysis as per defined SOP’s.

•  To make all resources available at site for analysing all samples as per defined SOP.
• To make sure testing are carried out as per Specification and within SOP timeline.
• To investigation/conclude any non-conformance occurred during analysis/process
• To implement/take adequate CAPA against non-conformance and monitoring of the same for effectiveness

Key Accountabilities (2/6)

Ensuring monitoring and on time completion of complaints/deviation/CAPA/regulatory compliances/FMECA/Audits and remaining activity pertaining to QMS.

• Monitoring of given KPI within QMS function and ensure complaince stated in respective SOP.
• Facilitate internal/external audits and ensure on time closure submission of response.
• Provide support to individual team member to complete activity as per SOP.

Key Accountabilities (3/6)

Ensure validation, Qualification and technology transfer activities executed as per schedule/SOP

• Monitoring of given KPI pertaining to stated function.
• Collaborating within CFT for on time validation, qualification of process/equipment’s/area etc and on time closure/execution of technology/product transfer.

Investigation, conclusion and on time closure of non-conformance like OOAC, OOAL, OOS, deviation and incidences

• Detailed investigation of non-conformance through RCA tools by taking personnel interview, 5why analysis, conducting cross functional meetings to find out the root cause within specified timeline.
• Based on root cause analysis implementation of CAPA.
• Ensure on time closure of non-conformances and CAPA

Key Accountabilities (4/6)

Ensure to perform / make availability of analytical method validation / verification

Ensure to perform analytical method validation and verification by verifying analytical method validation/verification protocols and reports.

Ensure on time launch of new product or tech transfer

• To be involved in product transfer/launch meetings/discussion.
• Arrange all relevant documents like method validation, material/product codes.
• To make availability of resources.
• To perform method transfer/validation/verification.
• To perform analysis of validation batches.

Key Accountabilities (5/6)

Ensure to achieve all assigned KPI

• To monitor and ensure to meet the RM, PM and FP productivity and SLA.
• To monitor and providing trainings on precautionary measures and techniques to analysts to reduce the manual error.
• To identify and robust the analytical methos of analysis.

To provide decision and technical assistant to analysts and section heads.

• Provide decision on technical matters or any kind of relevant information and analysis or any situations.
• Provide technical assistant on any kind of troubleshooting depending upon the situations/field and to train others on technical tools.

Key Accountabilities (6/6)

Major Challenges

Ensuring smooth function of respective functions by optimising/managing resources.

Ensuring on time delivery/analysis of products complying with all established SOP/guidelines.

Ensuring all time audit readiness and comply all the laid down process wrt functioning of lab.

Coordination with internal/external stakeholders to ensure functioning of laboratory.

Key Interactions (1/2)

• Address quality issues identified during analysis and during production/process and implementation of CAPA.
• Work closely with unit stakeholders to ensure new product meet quality specifications before launch and completion of validation/qualification.
• Resolve quality related issues and ensure timely resolution.
• Report on quality performance, compliance and improvement initiatives.
• Participate in recruitment and performance evaluation of  staff.
• Ensure compliance with internal and external audit observations

Key Interactions (2/2)

• Collaborate with IPD/service providers to resolve quality issues.
• Interact with internal and external agencies during audit and inspection.
• Collaborate with peers to benchmark quality standards and processes.

Dimensions (1/2)

• Sound knowledge of quality standards, tools and methodologies
• Good leadership and team management skill.
• Good communication skill and interpersonal skill

Dimensions (2/2)

Key Decisions (1/2)

Resource Allocation

Compliance

Training

Deliveries

Quality Standards

Process Improvement

CAPA

Key Decisions (2/2)

Allocate resources for activities

Ensure adherence to quality/regulatory standards. To provide the methodology to find out root cause during investigation of non conformance

Approve training programs for microbiologists

Completion of all microbiology related activities on time at site as per SOP

Implement quality policies and procedures

Approve initiatives to enhance quality and efficiency

Implement corrective and preventive actions for quality issues

Education Qualification

M.Sc. (Microbiology)

Relevant Work Experience

15-20 Years

Technical Skill, leadership skills, communication skills, Analytical Skills and should have CLE prospects.