Quality Control Lead

1 month ago

hyderabad, India StemCures Full time


Responsibilities

The Quality Control Specialist trains and becomes competent at performing,

interpreting and reporting for quality control assays required for cellular

product evaluation. Responsible for the quality control (QC) of reagents,

supplies, facility environmental testing, laboratory equipment maintenance

and QC performed in the Stem Cell Facility. The Quality Control Specialist is

responsible for QC procedures that are performed under the highest

standards of quality in a timely manner while minimizing costs


FLOW CYTOMETRY EXPERTISE IS MANDATORY


 Acts as an advisor to subordinates when determining how to meet schedules

and/or resolve technical problems. Reviews testing and laboratory records for

accuracy and compliance with cGMP and Lonza policies and principles.

 Develops and maintains a tool for monitoring QC resource capacity. Provides

feedback to management and production planners when capacity constraints

exist.  

 Work on development of QC Technical Services, Bio Analytical Services, and

program management to drive technical transfer, staff training, and

assay qualification/validation activities. 

 Leads, mentors, and coaches staff through routine one-on-one meetings,

team meetings, and effective performance management. Sets and delivers

on individual and team goals that support the department and site strategy. 

Takes personal accountability for both his/her own and the team’s actions.  

 Writes, reviews, and/or approves SOPs, sampling plans, protocols,

and specifications. 

 Prepares responses to audits, deviations, out of specification/lab

investigations, customer complaints, and corrective/preventative actions

(CAPA). Actively works to ensure responses are completed on-time. 

Escalates roadblocks to completion and provides potential solutions. 

 Prepares monthly management reports including budget analysis and

project updates. Actively monitors spending for area. Predicts and escalates

potential spending variances. Identifies corrective actions for spending

variances. 

 Develops and monitors team performance measures to understand

effectiveness, efficiency, and quality of group performance.


Qualifications

Masters in Biological Sciences/ MVSc/M. Pharm/ME/ M.Tech with experience

in stem cell research and genetic engineering experience are encouraged to

apply. Experience in a Quality Control role within a regulated environment.

Additional experience will be given due weightage.


Minimum 5 years of experience working in a biotechnology environment.

Familiarity with Pharmaceutical Industry related to cGMP, regulatory

standards and Biotech processes desirable.

 Experience working in QC required.

 GMP compliance knowledge including knowledge of National Regulatory

Authority, 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing

Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice

Medicinal Products for Human and Veterinary Use, including Annex 1 and

FDA Guidance on Aseptic Processing; ISO 9001:2015, 13485 and Part 11

compliance knowledge preferred.

 Demonstrated knowledge in biological, cell based assays including flow

cytometry and PCR.

 Experience with method validation and technology transfer.

 Proficient in the use of spreadsheets, databases, and word processing

software.

 Ability to perform statistical analysis of data.

 Knowledge of LIMS, SAP and TrackWise systems a plus.

 Experience with implementation of new QC Equipment preferred.

 Exposure to Six Sigma methodologies and concepts, including process

improvements / efficiency projects a plus.

 Effective leadership skills including strategic thinking, planning, and problem

solving.

 Effective Human Relations skills including promoting teamwork, creating

alliances, ensuring a high level of employee, patient, visitor, and external

stockholder satisfaction.

 Strong organizational and project management skills.

 Strong interpersonal skills to include the ability to facilitate, mentor, negotiate,

and work collaboratively with others.

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