Job Description

We are looking for enthusiasts KVALITO Consulting Group is a strategic partner and global Life Science network for regulated industries with a focus on quality. Headquartered in Basel, Switzerland, we have subsidiaries in Germany, Czech Republic, Ireland and Malaysia. With our enthusiasm for progressive technologies and our in-depth knowledge of industry best practices and regulations, we drive effective and efficient project delivery to keep our industry-leading clients ahead of the competition. Our leadership and consultants combine decades of experience in enterprise environments. To cover all essential technical areas in the field of digital and mobile, KVALITO works with reliable Technology Partners worldwide. For more information, please visit us at LifeScience Consultant: Junior Document Manager

Location: Malaysia(remote)

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

Responsibilities:

Qualified individuals will be responsible for the design, implementation, andmaintenance 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 in Veeva

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 minimal 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)
including experience in working cross-functionally and in global teams across cultures.

We offer great benefits

Flat hierarchies and responsibility from the beginning

People-oriented culture

Diversity and inclusion-focused environment

Global client projects in a multinational environment

Flexible working hours and home office

Involvement in global conferences

Individual professional development, training, and coaching

Unlimited full employment contract

Excellent remuneration package consisting of a competitive salary plus a substantial bonus

Contact

If you have the necessary background and experience and would like to join a small team responsible for a truly global operation, then please send your application to recruiting(at)kvalito.ch including your:

CV, cover letter, and supporting documents (i.e., diplomas, certificates, references)

Availability - earliest start date

Salary expectations

Location preference

We are looking forward to your application.
Your KVALITO Team.

Kvalito