Aurobindo Pharma USA, Inc.

QUALITY ASSURANCE ASSISTANT MANAGER

Job Locations US-NJ-East Windsor
ID
2021-2664
Category
Quality Assurance
Type
Aurohealth Pharma
Status
Full-Time

Division Overview

AuroHealth Logo (2)

Aurohealth LLC is a pharmaceutical company that develops, manufactures, markets and distributes store brand Over the Counter (OTC) products. Our mission is to develop as many OTC products for the US retail market providing a consistent and reliable supply, at a fair price, and of the highest quality. We are very customer focused organization that continuously seeks ways to be a reliable source for our customer’s needs.

 

Our targets include Rx to OTC switch molecules, ANDA & Monograph OTC products in various dosage forms / formats solids (tablets, capsules, soft gels), liquids, semi solids & nasal sprays. Our FDA approved manufacturing sites are located in USA & India.

Job Overview

GMP/GLP/GDP regulations and guidelines. Manages various QMS processes including Document & Records Control, Internal Audits, Supplier Management, Quality Agreements, Training, and CAPA. Compile data for documentation of test procedures and prepare reports. Create, advise on and support the establishment and continual improvement of Standard Operating Procedures and Work Instructions. Develop validation master plans based on FDA/EMA guidance for all processes and methods related to our lead product and follow on products (GMP).

Responsibilities

  • Manages various QMS processes including Document & Records Control, Internal Audits, Supplier Management, Quality Agreements, Training, and CAPA.
  • Compile data for documentation of test procedures and prepare reports.
  • Create, advise on and support the establishment and continual improvement of Standard Operating Procedures and Work Instructions.
  • Develop validation master plans based on FDA/EMA guidance for all processes and methods related to our lead product and follow on products (GMP).
  • Provides QA review and approval of production batch records and testing results, specification changes, product non-conformances, deviations and protocols/reports (e.g., validations, qualifications, capability, stability).
  • Executes Gap Analysis and/or Risk Assessments.
  • Develop the change control system including Corrective and Preventive Actions.
  • Develop and implement supplier qualification system and oversight program to fully qualify all suppliers, CMO and CRO.
  • Provide technical response and expertise during audits, inspections and due diligence.
  • Review and validation of all equipment and utilities.
  • Assure preclinical studies are performed in accordance with international Good Laboratory Practice (GLP) standards and Company policies & procedures.
  • Conduct or monitor audits to review protocol, data, reports and in-lab audits as per GLP requirements.
  • Supervise and guide inspectors.
  • Assure the reliability and consistency of production by checking processes and final output.
  • Primary facility/plant FDA contact.
  • Review current standards and policies.
  • Final QA Approval for Investigations, CAPA’s, Change Control, Field Alert Preparation.
  • Keep records of quality reports, statistical reviews and relevant documentation.

Qualifications - Skills & Requirements

  • Bachelor’s Degree in Pharmaceutical/Life/Technical Sciences.
  • Master or excellent knowledge of international regulations (e.g., FDA, GMP, ICH).
  • Up to 5 years of experience in Quality Assurance within a pharmaceutical field, including practice in conducting and/or monitoring audits.

Education & Experience

  • Bachelor’s Degree in Pharmaceutical/Life/Technical Sciences.
  • Master or excellent knowledge of international regulations (e.g., FDA, GMP, ICH).
  • Up to 5 years of experience in Quality Assurance within a pharmaceutical field, including practice in conducting and/or monitoring audits.

Physical Requirements

OFFICE POSITION - While performing the duties of this job the employee is required to: • Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment • Specific vision abilities required by this job include close vision requirements due to computer work • Light to moderate lifting is required • Moderate noise (i.e. business office with computers, phone, and printers, light traffic). • Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

Additional Physical Requirements

Blood/Fluid Exposure Risk

Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.

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