• SR Specialist , QA Release Jobs in United States Of America

  • Boehringer Ingelheim India Pvt Ltd
  • United States Of America, Usa
  • Save Job
  • 18 - 21 Years
  • Posted : above 1 month

Job Description:

SR Specialist, QA Release - 1911631

Description

The basic purpose of this position is review and approvals of batch records, government release documentation and release of starting materials, in process and finished biological product This position assures that all specifications are met prior to each stage of release to comply with USDA, and cGMP regulatory requirements relating to these areas The scope of support includes every stage of manufacturing in BIAH, including product received from 3rd Party contract manufacturing organizations (CMOs) This individual will be a resource for related technical and compliance information within the Quality and Compliance unit, as well as serve as a backup for the QA Release Group in the event of their absence

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies success We realize that our strength and competitive advantage lie with our people We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance Our competitive compensation and benefit programs reflect Boehringer Ingelheims high regard for our employees

Duties & Responsibilities

Documentation Review/Approvals

1) Batch record documentation review for compliance to Good Documentation Practices and against established SOPs/standards

2) Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP

3) Resolves major issues that are not defined by SOP

4) Performs review and approvals of APHIS Form 2008s against applicable Outlines of Production for submission to the USDA for all serial releases

5) Creates export documentation as appreciable specifically Certificates of Analysis for external agencies

6) Preforms documentation review of media fills and media fill protocol approvals as needed

7) Master Seed Inventory Management-issuance and reconciliation of master seed for operations

Change Control

1) Performs review and approvals of change controls as a subject matter expert (SME)in QA Release for routine change controls

2) Performs review and approvals of significant change controls (new facility/new equipment/new product) as applicable for assigned area

3) Completes change control action items as assigned

4) Revises existing procedures as changes occur

5) Creates new documents (SOPs/Forms/templates) as needed

Deviations/CAPA

1) Assesses, reviews and approves deviations for assigned area (dept approver) and assigns investigations as needed

2) Writes or participates in deviation investigations for determination of appropriate root causes

3) Serves as QA approver for investigations as needed

5) Performs follow-up on CAPAs for completion

Release Process

Performs Oracle release activity for intermediates and finished product, which includes manufacturing date entry, expiry date validity check, and status changes

Projects

1) Actively participates on project teams as assigned by supervisor

2) Coordinates and leads projects within group without supervision

Training

1) Completes all assigned training by target due dates as assigned by BIAH

2) Completes on the job training for each assigned job task

3) Cross train on other job tasks within department

4) Assists with training other individuals within the department on specific tasks

5) Performs training other individuals within department per assigned training plans

6) Assists QA management with the development of training plans within department and trains others

7) Develops training plans and trains others, including training outside of area of responsibility as training USDA Government samplers Responsible for USDA Government Sampler training program

Inspection

1) Performs review/release approval of serials/lots reports Oracle releases completion Regulatory

2) Demonstrates understanding of regulations for various countries

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 17th Mar 2020

Key Skills:

Company Profile:

Company
Boehringer Ingelheim India Pvt Ltdarfix

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