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Title:  Document Author

Date:  19 Dec 2024
Job Location:  Bangalore
Pay Grade: 
Year of Experience: 

JOB DESCRIPTION

 

Job Title: SOP/SPEC CREATOR (Author)

Job Location: Bengaluru

 

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 prepare the various documents like SOPs/IOPs/EOPs and other specifications with method of analysis as per the pharmacopeia/method validation/method verification etc.

 

Role Accountabilities:

To prepare and made the SOP/IOP/EOP/MOA and other required documents in time available for usage

 

Leadership Capabilities

To work collaboratively with the cross functional team members.

 

Syngene Values

 

All employees will consistently demonstrate alignment with our core values

 

  •  Excellence
  •  Integrity
  •  Professionalism

 

Accountabilities as a Syngene Leader (only for Leadership Hires)

  • Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities.
  • Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance.

 

  • Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority.

 

 

Specific requirements for this role

 

  1. Experience : 6-10 years
  2. Demonstrated Capability:

Sound analytical knowledge:

Hands on experience on the software like TRACKWISe, LIMS. EDMS and good skills in MS Office.

Ensure safety compliance in daily activities as per Syngene policy and EHSS requirement.

Overall adherence to safe practices and procedures.

Contributing to the development of procedures, practices and systems that ensures safe operations and compliance to the company’s integrity & quality standards.

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.

Initiation of QMS elements i.e. Change control, CAPA, deviation, Laboratory Incident, OOS, OOT, Non-Conformity as applicable.

Handling of LMS, LIMS, ELN, TrackWise and EDMS Softwares for routine activities as applicable

 

  1. Education:

Masters degree in chemistry/Bachler in Pharmacy or equivalant

 

Skill and Capabilities :

        1. Preparation of Product Specification, Standard Operating Procedure, Instrument Operating Procedures, General procedures. Observation data sheet, calibration data sheets, protocols and reports etc.
        2. Perform pharmacopeial/Regulatory Assessment /surveillance on introduction / revision of new / revised monograph and general chapters/guidelines.
        3. Reviewing LIMS/ELN relevant documentation, SOP’s, training presentations, and any other documents related to CSV requirement for any enhancements or new implementation/Modules. Collaborating with IT and QA to facilitate validation activities, writing/execution/review of Test Scripts, and effective implementation of LIMS. Ensuring the proper functioning of LIMS application as per the business needs through rigorous testing.
        4. Review of Specification, Standard Operating Procedure, Instrument Operating Procedures, General procedures. Observation data sheet, calibration data sheets, protocols and reports etc.
        5. Creation/ preparation of documents, master data/ static data creation in LIMS, ELN and LMS Softwares as applicable.
        6. Act as training coordinator for QC. Assignment of procedural training and recording training in LMS coordinating for internal and External training etc.
        7. Imparting training to New joiners, Consultants, Deputation Transfer etc.
        8. Preparation of Standard Qualification protocol, Report and COA as applicable.
        9. Archive and retrieve documents related to the working area/section.
        10. Adherence to Good Laboratory Practice and Good documentation practices.
        11. Cleaning of workplace and following Good laboratory practices while working in QC Laboratory.
        12. Individuals working in the GMP environment are responsible for documenting/record the activities contemporaneously and accurately as per Good documentation practices.
        13. Taking any other job allocated by Head QC / Group Leader /Section Head

 

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.

 

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