Document Senior Specialist

Bristol Myers Squibb

2 - 5 years

3 - 7 Lacs

hyderabad

Posted:6 days ago| Platform:

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Skills Required

product quality analytical pharma quality systems investigation clinical trials data privacy document management risk management continuous improvement

Work Mode

Work from Office

Job Type

Full Time

Job Description

This position is responsible for facilitating site procedural documents across areas of the QMS Framework and in association with electronic systems that support maintaining the QMS.
This includes, but not limited, to document authoring, coordination of review and comments resolution, approval, issuance, implementation, periodic review, and retirement.
Responsible for compliance assessment of procedural documents against Global Procedures and Policies
Maintain a contemporary knowledge of current industry trends, standards and methodologies as it relates to quality systems and document management.
Serves as the site Subject Matter Expert for procedures and their QMS and provides cross site support for a variety of different document management systems and process.
Support strategic initiatives and continuous improvement projects related to QMS
Synthesize feedback from SMEs/procedural document teams to identify and resolve issues in order to accurately document current and future processes
May be required to effectively manage projects, escalate issues as necessary and identify/meet key milestones
Work with guidance to manage the development of site procedural documents and, seek input as needed
May be required to be a representative for global document management initiatives and projects
Support site inspections and audits
Exercise sound judgment, using a risk-based approach, to ensure compliance with procedural document regulations, practices, and policies
Collect metrics to identify trends and take appropriate action
Responsible for communication of procedural document status to businesses
Maybe required to support the implementation and/or maintenance of additional QA Systems, which may include (but is not limited to) Documentation, Change Control, Quality Risk Management, Product Quality Complaints and Annual Product Quality Reviews
Support the completion of investigation/CAPA activities as required

Qualification and Experience

Education:

Minimum of a bachelor s degree
3+ years experience in the BioPharm/Pharmaceutical/Cell Therapy industry.
Cross-functional experience in one or more areas (i. e. research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT) is preferred
Experience with demonstrated knowledge in quality and/or compliance discipline with in-depth knowledge of cGMP requirements and global health authorities regulations
Experience/Knowledge: In depth knowledge of cGMP requirements and global health authority regulations with ability to interpret, apply and implement.
Experience in negotiating and influencing skills in a matrixed organization.
High level of competency in procedural document writing including the appropriate use of grammar, syntax and organization of ideas
Demonstrated ability to work independently with oversight from manager.
Ability to identify, manage, and/or escalate issues and risks to timelines.
Fluent in English, with proven professional working proficiency in English for reading, writing and speaking.

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