Senior Executive QA

Bengaluru - India

Monthly Salary: Not Disclosed

Posted on: 8 hours ago

Vacancies: 1 Vacancy

Job Summary

JOB DESCRIPTION

Job Role: Analytical QA analyst

Department : Quality Assurance BGRC

Job Location : Bangalore

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 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:

online documentation adhering to GDP practices.
review and approval of protocols and reports (Method validation Method Verification Method Transfers Study Compounding Stability).
review and approval of analytical documents (blank ODS executed ODS summary sheets specifications results analyst qualifications etc.)
Ensuring cGMP is followed in QA and QC.
Overall functioning of respective QC team activities.
Preparation and review of QMS trend reports.
Review and approval of instrument / equipment Qualification and calibration data.
Perform and approve periodic audit trial verification.
Review and approval quality assurance procedures.
Preparation of Qauality assurance procedures
Review and approval of quality control and CFT procedures.
Co-ordinate and investigate QMS.
Training of personnel in Quality Control Quality Assurance and other CFTs (wherever necessary).
Attendmandatory trainings as and when conducted.
Ensure effective archival activities
Execution of daily QA activities and maintenance of area.
Regular client interaction via telecom or e-mails.
Implementation of corrective and preventive actions and monitoring its effectiveness (wherever applicable).
Review and approval of CFT documents like EAM IT etc.
Issue documents from EDMS and reconciliation of the same.
Perform initiator / QA reviewer role in Trackwise.
Perform reviewer / approver role in EDMS
Collate and prepare slides for QRM Metrics meeting.
Prepare review and approval of planners.
Issuance and withdrawal of logbook procedures schedules etc. wherever applicable and maintenance of issuance/ withdrawal records.
Monitoring the usage of current approved procedures in all relevant departments.
Ensuring safe operation within BGRC QA and accordingly to ensure zero safety incidents. Ensure to report safety incidents/Near miss if any and 100% safety related training compliance.
Escalating the abnormalities/gaps in procedures if any to reporting manager/ HOD or user department (where applicable).
Ensuring no document is re-opened or leads to non-conformity or observation due to lack of review against the defined procedure.
Ensuring approved documents have no gaps including compliance related to good documentation practices.
Execution and approval of ISO 17025:2017 requirements at BGRC.

Syngene Values

All employees will consistently demonstrate alignment with our core values

Excellence
Integrity
Professionalism

Specific requirements for this role

Experience

Foundational

Behavioural Skills

Good Interpersonal skills
Self-time management
Good team player
Good communication skills

Education

(Analytical chemistry/Chemistry)

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.

Required Experience:

Senior IC

JOB DESCRIPTIONJob Role: Analytical QA analyst Department : Quality Assurance BGRCJob Location : BangaloreAbout Syngene :Syngene ()is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.At...