NewBrunswickRecruiter Since 2001
the smart solution for New Brunswick jobs

Compliance Specialist

Company: Alpha Consulting
Location: New Brunswick
Posted on: January 11, 2021

Job Description:

COMPLIANCE SPECIALISTNEW BRUNSWICK, NJProject Description:* Managing and coordinating activities related to cGMP Enterprise Electronic Systems. * Duties include leading, developing, and maintaining compliance activities across IT Enterprise Services supported regulated GPS applications. * Responsible for developing policies and procedures and coordinating all activities relevant between the Quality departments, IT validation and information technology in relation to implementation, maintenance and change control of computerized systems.* A key focus of this role will be to provide quality/compliance oversight to all computer system validation related activities across the GPS enterprise. * The manager will guide the staff to ensure a comprehensive System Development Lifecycle Methodology in alignment with GAMP 5 requirements.* This role will also provide support services and governance to all supporting IT areas (GPS corporate and sites) to ensure global alignment to the computer compliance, global validation and change control standards.* Responsibilities also include providing support to assigned Quality programs, such as Data Integrity Governance, Investigations, Global Quality Headquarters Training and other, as assignedOther responsibilities:* Evaluates and administers consultation on computer validation issues related to Quality related computer systems; works closely with Information Technology and Quality Operations on these related issues.* Ensures enterprise level metrics and tracking for Corporate Computer related CAPAs are maintained and reported appropriately.* Develops and implements policies and procedures related to Quality related system compliance activities related to Risk assessments, validation and the overall maintenance of system state of control.* Ensures compliance with all Company policies and procedures, including safety rules and regulations.* Partners with IT Validation to ensure risk assessments, incident management and oversight are aligned to corporate and data protection standards.* Performs related duties as assigned.Required Skills:* 21CFR11/ EU GMP Annex 11 and GAMP 5 standards* Data Integrity Guidance* Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements* Project management practices and techniques* Software development life cycle* Computer hardware and software applications including Quality related computer systems, MS Office and MS Project* Principles and practices of computer compliance, validation and qualification* Knowledge of automated testing practices and tools a plus* External and internal inspectionsSkilled in:* Stakeholder management in a cross-functional organization* Reviewing user, functional and design specifications.* Reviewing and executing protocols and test scripts* Sampling, testing and measuring techniques.* Analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution.* Selecting, training, supervising and evaluating departmental personnel* Managing multiple projects, duties and tasks,* Communicating clearly and concisely, both orally and in writing.* Establishing and maintaining effective working relationships with those contacted in the course of work.* Bachelor's degree in a related field from an accredited college or university, with a minimum of 5 years of related experience This 6+ month position starts ASAP.Please E-MAIL your resume (attachment to email) with rate and availability to Purvi: purvi@alphaconsulting.comALPHA'S REQUIREMENT #20-02080MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE#ZR

Keywords: Alpha Consulting, New Brunswick , Compliance Specialist, Other , New Brunswick, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Deliver Food with Uber - Flexible Gig
Description: Job DescriptionDeliver with Uber. Earn on your schedule. Work on your schedule. Deliver for a few hours in the mornings, every night, or just on weekends--it's up to you. Earn Good Money. You'll
Company: Uber Eats
Location: Bayport
Posted on: 01/19/2021

QC Inspector
Description: Job DescriptionLehigh Technical Professional Service is a leading staffing agency dating back to the 1950's. We specialize in temporary and direct placement positions in the fields of: IT, Engineering, (more...)
Company: Lehigh Technical
Location: Holtsville
Posted on: 01/19/2021

Experienced Body Tech
Description: Job Summary Experienced Auto Body Technician needed to repair vehicles thoroughly, safely, and profitably in a manner consistent with Caliber S.O.P., insurance partner and industry guidelines/standards. (more...)
Company: Caliber Collision
Location: Medford
Posted on: 01/19/2021


Hiring Immediately: Coca Cola
Description: Easy Application
Company: Coca Cola.com
Location: Holtsville
Posted on: 01/19/2021

Hair Stylist
Description: Sport Clips Haircuts is Hiring Hair Stylists Do What You Love. Love What You Do.JOB DESCRIPTIONOur salon is looking for talented hair stylists who are passionate about cutting hair and making their clients (more...)
Company: Sport Clips - SELDEN
Location: Selden
Posted on: 01/19/2021

RN / Registered Nurse / New York / Any / Family Nurse Practitioner - F
Description: FAMILY NURSE PRACTITIONER NEEDED ON LONG ISLAND
Company: KA Recruiting, Inc.
Location: Bohemia
Posted on: 01/19/2021

Lead Coordinator, QA Document Review (I)
Description: Company DescriptionThe Nature's Bounty Co. is a privately held, global leader in health and wellness with a rich history and proven track record in the nutritional market. As a manufacturer, marketer (more...)
Company: The Nature's Bounty Co.
Location: Bohemia
Posted on: 01/19/2021

Family Nurse Practitioner - Urgent Care (Nurse Practitioner #)
Description: Urgent Care opening in Medford, New York. Full-time Family Nurse Practitioner needed at
Company: KA Recruiting Inc.
Location: Medford
Posted on: 01/19/2021

Need a gig? Deliver with Uber Eats!
Description: Job DescriptionDeliver with Uber. Earn on your schedule. Deliver with Uber Eats on your schedule. Deliver for a few hours in the mornings, every night, or just on weekends--it's up to you. Earn Extra (more...)
Company: Uber Eats
Location: Mastic
Posted on: 01/19/2021

Physician / Surgery - Plastic / New York / Permanent / Cosmetic Plasti
Description: Looking for Plastic surgeon interested in breast and body work. Currently
Company: Confidential
Location: Smithtown
Posted on: 01/19/2021

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

New Brunswick RSS job feeds