Quality Assurance Engineer

7 days ago

New Brunswick, New Jersey, United States Sun Pharmaceutical Industries Full time

Position Title: Quality Assurance Engineer - Pharmaceutical Sector

Overview:

The Quality Assurance Engineer plays a crucial role in executing validation processes for equipment, packaging, computer systems, and utility equipment, ensuring compliance with current Good Manufacturing Practices (cGMP).

Experience Requirement:

A minimum of four (4) years in the Pharmaceutical industry, with a focus on Oral Solid Dosage forms.

Key Responsibilities:

  • Develop and implement User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, along with summarizing reports for production and packaging machinery, as well as utility systems including HVAC, air compressors, boilers, and purified water systems.
  • Ensure timely execution of validation tasks in accordance with established cGMP standards.
  • Coordinate commissioning activities for engineering projects involving new areas and equipment.
  • Review and conduct Periodic Performance Verification (PPV) of equipment.
  • Create calibration plans for newly acquired equipment.
  • Prepare and conduct training for Standard Operating Procedures (SOPs) related to setup, operation, cleaning, and maintenance.
  • Identify, analyze, and resolve deviations across multiple ongoing projects.
  • Facilitate the preparation of personnel flow, incoming and finished material flow, and waste management within the facility.
  • Assist in the preparation of responses for internal audits and regulatory agency inspections.
  • Draft, review, approve, and maintain Validation Project Plans, Summary Reports, and other essential validation lifecycle documentation.
  • Timely completion of investigations and documentation.
  • Manage and close all change controls, Corrective and Preventive Actions (CAPA), and investigations promptly.
  • Develop SOPs for facilities and utilities.
  • Monitor work order progress to ensure accurate completion and filing, collaborating with maintenance teams to resolve outstanding work orders efficiently.
Education and Qualifications:
  • Bachelor's Degree in Engineering or a related scientific discipline.
  • Strong technical and analytical skills to evaluate engineered systems and equipment operations, as well as quality and compliance frameworks supporting production and research activities.
  • Comprehensive understanding of cGMP regulations and proficient documentation practices necessary for creating technical documents throughout the system lifecycle, including URS, Functional Requirement Specifications (FRS), Validation Master Plans (VMP), protocol generation, and execution for Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, qualification (IQ, OQ), SOPs, and validation (PQ, Design Specifications (DS), Cleaning Validation (CV), Performance Validation (PV), and FMEA).
  • Proficient in drafting, preparing, and executing Change Controls, Investigations, SOPs, protocols, final summary reports, and validation documentation.
  • Exceptional communication skills, both verbal and written, along with strong presentation abilities.
  • A proactive self-starter with a hands-on approach and a positive attitude.
  • A champion of team building, fostering innovative cross-functional collaboration.
  • Excellent project management and problem-solving capabilities.
Language Proficiency:
The role requires an Intermediate-B1+ level of English proficiency based on the Common European Framework of Reference for Languages (CEFR).

Compensation and Benefits:
The compensation structure may vary based on several factors, including geographical location and individual experience. This position is eligible for the Annual Performance Bonus Plan and participates in various employee benefit programs, which encompass medical, dental, and vision coverage; life and disability insurance; a 401(k) savings plan; flexible spending accounts; and an employee assistance program. Employees also enjoy various paid time off benefits, including vacation and sick leave.

EEO Statement:
We are committed to providing equal employment opportunities to all current employees and applicants. This policy prohibits discrimination based on race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, or any other basis prohibited by law.

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