Document Control Specialist at Precision for Medicine

Pune, maharashtra, India -

Full Time

Start Date

Immediate

Expiry Date

03 Feb, 26

Salary

0.0

Posted On

05 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Document Control, Quality Assurance, Training, Audits, Microsoft Office, Quality Management System, Compliance, Process Improvement, Documentation, Team Player, Communication, Attention to Detail, Flexibility, Record Management, Administrative Support, Problem Solving

Industry

Pharmaceutical Manufacturing

Description

Position Summary: The Document Control Specialist will be responsible for the maintenance and management of controlled documents and records for Precision for Medicine as well as provide administrative support to the quality assurance team. Essential functions of the job include but are not limited to: Quality Assurance, Document Control - General Facilitate the electronic document control process regarding new or existing Quality System Documents, and other related records, and tracking the status of documents during their life cycle: draft, peer review, approved, effective, retired / obsolete, etc. Work with owners/originators, reviewers and approvers to facilitate document control workflow, ensuring proper document formatting and organization Ensure right-first-time review prior to formal review process, by quality management, to ensure good documentation practices, readability (clear and concise, spelling) and compliance with internal and external standards. This includes reporting gaps to senior management and providing guidance to document owners regarding how to create, remediate or correct documents Assist with Quality Systems Improvement such as harmonization of the Global Quality Management System, process improvements, and other system changes as needed. Assign training workflows for new or revised quality system procedures and for new employees Maintain document security. Coordinate Periodic Review of Documents to owners. Training Conduct training for new and existing employees on electronic quality management system as needed. Audits Assist during audits as needed. Pulling employee Dossiers or physical training records. Answer any questions related to the Quality Management System (QMS) Pull archived documentation and archived controlled documentation from the Quality Management System (QMS). Qualifications: Minimum Required: Bachelor’s degree 2-3 years of experience QMS Management, including document/record control. Working knowledge of quality and documents in a regulated environment. Other Required: Ability to meet deadlines and perform administrative functions Microsoft Office suite proficiency Must be a flexible agile team player who can change activities and directions quickly and respond to a variety of assignments and changing business needs. Must be able to read, write, speak, fluently and comprehend the English language Other duties Other duties as defined by management Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Responsibilities

The Document Control Specialist will manage controlled documents and records, ensuring compliance with quality standards. They will facilitate document control workflows and assist with quality systems improvement.