Junior Life Science Consultant, Document Management

1 week ago

Next Job, India Kvalito Full time
We are looking for enthusiasts


The purpose of the role is to work with our clients to understand their needs in document management, offer advice, solve problems, manage change, and improve efficiency.


Responsibilities:

Qualified individuals will be responsible for the design, implementation, and maintenance of the Quality Assurance Documentation and Change Management. Responsibility for issuance, tracking, and control of Standard Operating Procedures, Master Batch Records, Test Records, Forms, Protocols, Amendments,
and Final Reports including formatting, editing, and revisions. Serve as administrator current and future quality documentation systems and or software systems. Individual will assist the QS Manager in maintaining a complete Quality Management System (QMS) in compliance to cGMPs. Create, revise and maintain company standard operating procedures (SOPs) as required. Format, track and issue controlled cGMP documents including protocols, test records and forms.

Assist in the review of cGMP controlled documents as necessary Issuance of batch production records, tracking of master batch records, tracking of all batch production records and lot number issuance.

Maintain validation files (validation protocols, validation summary reports, engineering change controls). Interface with other departments regarding documentation requirements. Participate in and support quality audits (internal and external), troubleshooting efforts, and other Quality System processes. Provide backup and support to the Quality Assurance Manager Initiate, carry out and maintain change control documents Minimum Qualification and Experience
Education Bachelor or Master degree in Life Sciences, Chemistry, Computer Science, Engineering or similar. Language Fluent in English Work experience 1 -3 years' experience in manufacturing cGMP environment performing Quality Documentation duties. Hard Skills Knowledge and expertise

in principles and practice of current Good Manufacturing Practices (cGMPs).

Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and great sense of urgency while ensuring that all cGMP and Regulatory requirements are met.

Solid computer skills using Word, Excel, and PowerPoint Knowledge as a Veeva user is a must, and any other document management system is a plus Solid computer skills using Word, Excel, and PowerPoint Practical experience in and passion for information governance, IT quality, administration, and service management.

Familiar with compliance requirements (e.g.,FDA, EMA GMP, GLP, GCP, Records Management) Soft Skills Excellent people management, leadership, and decision-making skills.

Ability to facilitate a holistic perspective and understand business needs. Motivated to continuously expand her/his knowledge of the life science industry. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems.

The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under mínimal supervision without neglecting attention to detail The ability to enable and drive change while being focused on internal and external customers.

Strong communication and problem-solving skills. Ability to work globally to coordinate the work of associates at all levels. Capable of managing multiple priorities Considerable organization awareness (e.g., the interrelationship of departments, business priorities)
Your KVALITO Team.

Employment type:
Contract

JOB TYPE

Work Day:
Full Time

Salary:
Negotiable

JOB REQUIREMENTS
Minimal experience:3 years

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