Overview

QC Compliance Head Job at Sun Pharmaceutical Industries, Inc. – 3.8 New Brunswick, NJ

The QC Compliance Section Head leads and manages compliance related activities in Quality Control, focusing on out of specification (OOS), out of trend (OOT), Laboratory Events, CAPAs, and change controls. Responsible to manage laboratory test methods and specifications, revisions of operational procedures, and driving implementation of global documents. Responsible for meteorology activities in QC lab. Determines Quality Control KPI’s and metrics and identifies potential process improvements. Ensures inspection readiness and is able to respond to any audit observations.

Lead and manage compliance related activities in Quality Control including, but not limited to deviations (i.e. OOS, OOT, and Laboratory Events), CAPAs, and change controls.

This is a supervisory position with direct reports; therefore, this position will establish goals and objectives, prepare performance appraisals, monitor/review work product and coach/mentor direct reports.

Provide technical support, apply expertise, and critical thinking to help resolve technical and compliance issues.

Monitor and ensure timely closure of all laboratory related Quality Management System records.

Review and approve new and revised test methods and specifications.

Review and approve laboratory operational procedures, training materials, and procedures for various systems.

Drive implementation of global documents related to Quality Control functions.

Participate in and reviews/approves laboratory investigations.

Represents Quality Control at cross-functional meetings.

Lead QC metrology program of QC lab that includes instrument IQ/OP/PQ/Maintenance etc.

Establish, determine, and drive the improvement in established KPI’s / metrics for the Quality Control laboratory.

Trend OOS, OOT, and Laboratory Events to identify process improvements.

Assist in ensuring inspection readiness.

Assist in responses to any internal audit, corporate audit, or regulatory audit observations involving Quality Control.

This is supervisory position with direct reports; therefore, this position will establish goals and objectives, prepare performance appraisals, monitor/review work product and coach/mentor direct reports

Qualifications

Minimum BS or equivalent degree in Chemistry or related filed. MS/Ph.D. preferred.

Minimum of ten (10) years of experience in pharmaceutical laboratory.

Experience in pharmaceutical QC laboratory with management experience.

Must be familiar with cGMP/GLP practices for analytical laboratories, and with ICH and FDA guidance.

Excellent knowledge of HPLC, UPLC, GC, UV-Vis, Dissolution, FTIR, LC-MS, ICP-MS and other analytical instruments. Excellent working knowledge of USP, EP, ICH and FDA guidelines

The ability to organize complex work assignments and oversee analysts and staff to complete tasks andprojects on time.

Demonstrated technical project management experience to develop project goals, deliverables, and timelines.

Well versed with Microsoft Office. Must have laboratory investigation technique and writing skills.

Knowledge of relevant compendia, chemical assays and general lab equipment.

Ability developing project goals, deliverables and timelines.

Demonstrated excellent communication: verbal, written and presentation skills.

A self-starter with a hands-on approach and a can-do attitude.

A team building champion driving innovative cross functional synergies.

Excellent project management and problem solving skills

The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to GlobalCEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).

About the Company

Company: Sun Pharmaceutical Industries, Inc. – 3.8

Company Location:  New Brunswick, NJ

Estimated Salary:

About Sun Pharmaceutical Industries, Inc. - 3.8