Title:  Document Controller and Archivist

Date:  10 Jul 2024
Job Location:  Bangalore
Pay Grade:  9-I
Year of Experience:  0 - 3 Years

 

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-accountable for the achievement of safety goals

 

Core Purpose of the Role: To Perform the archival related and document controller activity by adhering to the guideline and SOP.

 

Role Accountabilities

  • Quality Management System (QMS):
  • Responsible for performing activity in track wise as per the assigned role.
  • Standard Operating Procedures’ (SOPs’):
  • Preparation and revision of SOPs’ 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) SOPs’ - current as well as obsolete SOPs’. Any other responsibilities as indicated in relevant SOPs’. 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.
  • Qualification and validation:
  • Review of qualification and validation documents related to Quality management system.
  • Share best practices and ideas with fellow QA personnel.
  • Analyze the root-cause for non-compliance / deviations; analyze trends observed (if any) and advice on resolving issues.
  • Suggest improvement potential and best practices.
  • Communicate lessons learnt to fellow QA personnel and apply the best practices across departments.
  • Sponsor audits:
  • Participate in Sponsor audits by preparing for the audit - liaising with the relevant department for preparation. Interact with Sponsor auditors - answer queries during the audit. Oversee the preparation and review of corrective and preventive action plan for the QMS related queries.
  • Regulatory inspections:
  • Participate in Regulatory inspections by preparing- liaising with the relevant department for the preparation; review documents, conduct mock-audits, guide personnel. Interact with Regulatory inspectors - accompany and answer queries during the audit. Prepare and review corrective and preventive action plan and follow-up on the implementation of the same.
  • 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.
  • Management Review:
  • Collation of data for the management review meetings.
  • Preparation of presentations for the review meetings.
  • 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.
  • Safety:
  • 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 always.
  •    Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements always 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 always.
  • Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time.

Syngene Values

 

All employees will consistently demonstrate alignment with our core values

 

  •  Excellence
  •  Integrity
  •  Professionalism

Specific requirements for this role

 

  1. Interest to learn new application softwares

 

Experience

 

  • 0-2 yrs relevant experience

Education

 

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.