Author and Document Reviewer
Author and Document Reviewer
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Job Description
JOB DESCRIPTION
Job Title: Author and Document Reviewer
Job Location: Syngene International Limited Bengaluru
About Syngene: Syngene () 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 companys 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 integrityhealth 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:
This is an exciting opportunity to play a role in Quality control department of Syngene. The role will provide several responsibilities of Preparation of Product Specification Standard Operating Procedure Instrument Operating Procedures General procedures. Observation data sheets calibration data sheets protocols and reports etc. Handling of LMS LIMS ELN TrackWise and EDMS Softwares for routine activities as applicable. Lab safety requirements and Compliance as per Syngene policy and EHSS requirement.
Role Accountabilities
- 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.
- Preparation of Product Specification Standard Operating Procedure Instrument Operating Procedures General procedures. Observation data sheet calibration data sheets protocols and reports etc.
- Perform pharmacopeial/Regulatory Assessment /
surveillance on introduction / revision of new / revised monograph and general chapters/guidelines.
- Reviewing LIMS/ELN relevant documentation SOPs 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.
- Review of Specification Standard Operating Procedure Instrument Operating Procedures General procedures. Observation data sheet calibration data sheets protocols and reports etc.
- Creation/ preparation of documents master data/ static data creation in LIMS ELN and LMS Softwares as applicable.
- Review of documents and records related to routine operations in quality control. Review of documents in EDMS and TrackWise.
- Involving in Investigation and closure of OOS OOT Laboratory incidences deviation and Non-Conformity as applicable.
- Check consignment documents like COA MSDS GRN TRF FTRF etc and monitor sampling of Raw materials packing materials In-process Validation Finished products water sampling and miscellaneous materials as applicable and certify the accuracy adequacy and timeliness of the activity performed by analysts.
- Responsible for imparting training to New joiners Consultants Deputation Transfer etc.
- Record updation for Outsourcing of sample testing based on requirement and updating respective Logbooks.
- Preparation of Standard Qualification protocol Report and COA as applicable.
- Archive and retrieve documents related to the section.
- Act as training coordinator for QC. Assignment of procedural training and recording training in LMS coordinating for internal and External trainings etc.
- Adherence to Good Laboratory Practice and Good documentation practices.
- Cleaning of workplace and following Good Laboratories Practices while working in QC Laboratory.
- Individuals working in the GMP environment are responsible for documenting/record the activities contemporaneously and accurately as per Good documentation practices.
- Responsible for taking any other job allocated by Head QC / Group Leader /Section Head.
Syngene Values
All employees will consistently demonstrate alignment with our core values
- Excellence
- Integrity
- Professionalism
Specific requirements for this role
- Experience
- Demonstrated Capability
- Education
Experience: 6 to 9 years
Skills and Capabilities
Expertise in handling multiple activities in Pharmaceutical Industry.
Capable of thinking scientifically to address complex problems and develop solutions.
Work as a team and have a collaborative mindset.
Good communication skills.
Education: MSC/ B. Pharma
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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.
Employment Type
Full Time
