Document Controller and Archivist

JOB DESCRIPTION

Job Title: Document Controller and Archivist

Job Location: Bangalore

About Syngene : Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Core Purpose of the Role: To perform Document Controller and Archival activity.

Role Accountabilities:

• Quality Management System (QMS):
• Responsible for performing activity in track wise as per the assigned role.

Standard Operating Procedures (SOPs ):

• Provide inputs in the revision of SOP s relevant to QMS area. Management of issue of SOP s, forms and logbooks to relevant departments; retrieval of obsolete SOP s, control of master (original)SOP s -current as well as obsolete Sop s. Any other responsibilities as indicated in relevant SOP s.
• Responsible for performing all the activities as EDMS coordinator.

Record control

• Ensure that all records are written legible. Control and maintain records in the QA department.
• Sponsor Audits.
• Coordinate sponsor audits by providing audit related documents to the audit facilitator.

Regulatory inspections:

• Coordinate regulatory audits by providing audit related documents to the audit facilitator.

Training:

• Responsible for performing all the activities as Training coordinator/ LMS coordinator. Identify training needs from audit experience and communicate to Head, QA and / or HR department. Inculcate the habit of self-development and participate in group discussions, seminars, workshops, etc. Drive education of document control across the organization. Train personnel in relevant guidelines and regulations.

Archives:

• Develop and implement all archives related procedures and practices as per SOPs regarding facility maintenance as per the EHSS and Engineering Maintenance department practices.
• Managing and Budgeting for internal and external (Third party) archives.
• Tracking of budget on a periodic interval.

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Specific requirements for this role

1. Experience
2. Demonstrated Capability
3. Education

Experience: 3-6 years

Skills and Capabilities:

• Experience in handling the Electronic Document Management System, Trackwise application and the Learning Management System.
• Should have understanding on the Quality Management System
• Basic understanding on the GCP Requirements.
• Knowledge on the Power BI is an added advantage.

Education: Master s in life sciences

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.