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Principal Investigator (QMS)

Company: Aurobindo Pharma Ltd.
Location: Cranbury
Posted on: April 1, 2024

Job Description:

Division OverviewEugia is US-based independent specialty pharmaceutical company focused on generic sterile injectables, oncology, hormones, and ophthalmic medicines. Eugia has best-in-class, dedicated manufacturing and R&D capabilities to meet customer needs as they emerge. We are committed to consistently providing our customers with high quality specialty medicines.Eugia's mission is to make the process of buying specialty pharmaceutical products an experience customers look forward to, and our vision is to become synonymous with excellent customer service and continuously improve upon this excellence by being transparent, responsive, and consistent. We are expanding Eugia's capabilities to include the manufacture of highly complex injectables to answer that need.Eugia is the partner of choice to deliver on the promise of generic specialty pharmaceuticals.Job OverviewThe Principal Investigator is responsible for the management and integrity of the design, conduct, and reporting of QMS elements and for managing, monitoring, and ensuring the integrity of any collaborative relationships.This role is located onsite in East Windsor NJ - candidate must live within a commutable distance.Responsibilities* Authoring and resolution of deviations, change controls, CAPAs, or documents to meet production and product release requirements.* Identification and facilitation of interdepartmental process improvements.* Utilize root cause analysis techniques during deviation investigational process.* Work cross-functionally, to develop and implement continuous process improvements.* Support production needs and continuous improvement including change control, deviation writing/review, CAPA implementation, and operational optimization.* Write, review, revise, and prepare manufacturing documents (BPR, SOP, WI) in accordance with cGMP and regulatory guidelines.* Communicate across multiple groups and levels to obtain consensus to facilitate deviation closure.* Manage multiple priorities either independently or as part of a team to meet key deadlines and communicate issues and progress across all levels of the organization.* Accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.* Must have knowledge of continuous improvement techniques and critical thinking skills.* Previous experience working within a production department of a pharmaceutical company preferred.* The candidate must be able to work extended and flexible hours (including weekends) when needed.* Expertise in developing lyophilized and sterile drug product manufacturing processes.* Experience in Sterile drug product process development, Microbiology, Facility Engineering, Manufacturing, Supply Chain, Validation, and EHS* Experience in the application of state-of-the-art laboratory equipment and software.* Experience evaluating, developing, and qualifying manufacturing equipment.* Sterile product development includes formulation, stability, process development/characterization and technical transfer.* Bioanalytical and biophysical testing, and data analysis* Demonstration of data integrity principles* Mentoring/developing staff in proper scientific study design, execution, and report writing.This is not an exhaustive list of all responsibilities, duties, skills, efforts, or requirements associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice.Qualifications - Skills & Requirements* Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take transfer sponsorship of an employment Visa at this time* Ability to follow written instructions precisely and perform basic math calculations.* Understanding/knowledge of cGMP, safety criteria or the ability to learn* He/she should have basic computer knowledge.* He/ she should know how to operate a reach truckEducation & Experience* High School Diploma and 3+ years' cGMP experience.* Associate degree and 2+ years' cGMP experience* Bachelor's degree and 1+ years' cGMP experiencePhysical RequirementsOFFICE 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 RequirementsNo Additional RequirementsBlood/Fluid Exposure RiskCategory III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.

Keywords: Aurobindo Pharma Ltd., East Brunswick , Principal Investigator (QMS), Education / Teaching , Cranbury, New Jersey

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