Job Brief:

• Required Citizenship / Work Permit / Visa Status:

US Citizen / Green Card Holder /H1B

 

• Must Haves:

The candidate must have a Bachelor's in Pharmaceuticals or in a relevant field of study.

The candidate must have at least 9 years of experience in Quality Control (QC) function of a pharmaceutical organization.

The candidate must have at least 2-3 years of supervisory/managerial experience.

 

Responsibilities:

1. Key Accountabilities

Accountability Cluster

Major Activities / Tasks

I. Plan the quality control routine operations and stability studies in order to ensure timely completion of stability studies and smooth functioning of release activity

· Monitor the commitment dates for release of RM, PM, FP & water analysis and process/cleaning validation section by conducting performance dialogues and handshake

· Review the plans prepared and monitor timely execution of activities in all the shifts to avoid delays

· Review the monthly planner and production plans to ensure timely availability of required resources and ensure no sample is overdue

II. Monitor the execution of all routine quality control operation and stability studies to ensure timely delivery and meet regulatory requirements and cGMP, GLP guidelines

· Monitor routine/stability operations closely and ensure that all necessary SOPs are followed by the team

· Provide technical guidance related to troubleshooting in chromatography, experimentation design etc. to minimize non-conformances

· Monitor timely implementation of new updates in specifications and QCPs to meet compliance

· Perform online review of reports generated to ensure zero data integrity issues in Lab

· Monitor sample charging and sample pull-out as per schedule

· Monitor reserved samples storage and destruction as per schedule and perform UD release

· Monitor the stability chamber daily for excursions and other related issues

III. Drive the investigation of the batch for non-conformance and ensure its closure within the timelines defined in SOPs to facilitate smooth operations

· Evaluate root cause analysis in case of OOS, OOT, incidences and rejection and propose CAPAs

· Investigate the stability chamber excursions and propose CAPAs

· Ensure that all non-conformances are routed through proper channel and are investigated as per SOP

· Communicate with respective QC/QA heads for compliance and ensure timely closure of CAPAs by tracking in SmartSolve

IV. Monitor completion of stability studies as per protocol/schedule to avoid delays in product launch

· Perform analysis for stability samples without any errors as per schedule

· Ensure timely completion of ANDA samples testing and submission of data by verifying it with ANDA schedule

· Plan the routine/stability activities by coordinating with ADL/R&D about dates of product dossier filing

· Resolve analytical and product related issues by escalating to ADL, R&D and transfer unit

V. Provide technical guidance to the team w.r.t batch release and stability studies and evaluate their performance to ensure team development and improved lab efficiency

· Identify the training needs of employees based on the updates in the pharmacopeial guidelines

· Monitor the training imparted on laboratory techniques, quality control procedures and principles of cGMP & GLP

· Monitor the productivity of all the teams in the section by reviewing %SLA and %NC rates

· Ensure the completion of training and qualification of analyst by taking feedback and timely reviewing his work

Skills Required:

The candidate must have at least 9 years of experience in Quality Control (QC) function of a pharmaceutical organization.

The candidate must have at least 2-3 years of supervisory/managerial experience.