Author and Document Reviewer

Syngene International

Bangalore, Karnataka
Permanent
Full-time

9 days ago

JOB DESCRIPTIONJob Title: Author and Document ReviewerJob Location: Syngene International Limited, BengaluruAbout 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 spiritMandatory 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: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, 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.

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 ValuesAll 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 yearsSkills and CapabilitiesExpertise 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. PharmaEqual Opportunity EmployerIt 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.

Syngene International

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