Job Description

JOB DESCRIPTIONJob Role: Quality Assurance Analyst
Department: Quality Assurance - BGRCJob Location: BangaloreAbout 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

Role Accountabilities:

• Responsible for online documentation adhering to GDP practices.
• Authorized for review and approval of protocols and reports (Method validation, Method Verification, Method Transfers, Study, Compounding Stability).
• Authorized for review and approval of analytical documents (blank ODS, executed ODS, summary sheets, specifications, results, analyst qualifications, etc.)
• Responsible for ensuring cGMP is followed in QA and QC.
• Responsible for the overall functioning of respective QC team activities.
• Authorized for preparation and review of QMS trend reports.
• Authorized for review and approval of instrument / equipment Qualification and calibration data.
• Authorized to perform and approve periodic audit trial verification.
• Authorized to review and approval quality assurance procedures.
• Responsible to assist in preparation of auality assurance procedures
• Responsible for review and approval of quality control and CFT procedures.
• Authorized to co-ordinate and investigate QMS.
• Authorized for training of personnel in Quality Control, Quality Assurance and other CFTs (wherever necessary).
• Attend mandatory trainings as and when conducted.
• Responsible to ensure effective archival activities
• Responsible for execution of daily QA activities and maintenance of area.
• Responsible for regular client interaction via telecom or e-mails.

• Responsible for implementation of corrective and preventive actions and monitoring its effectiveness (wherever applicable).
• Authorized and review and approval of CFT documents like EAM, IT, etc.
• Authorized to issue documents from EDMS and reconciliation of the same.
• Authorized to perform initiator / QA reviewer role in Trackwise.
• Authorized to perform reviewer / approver role in EDMS
• Responsible to collate and prepare slides for QRM, Metrics meeting.
• Authorized to prepare, review and approval of planners.
• Authorized for issuance and withdrawal of logbook, procedures, schedules, etc. wherever applicable and maintenance of issuance/ withdrawal records.
• Responsible for monitoring the usage of current approved procedures in all relevant departments.
• Responsible for 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.
• Responsible for escalating the abnormalities/gaps in procedures if any, to reporting manager/ HOD or user department (where applicable).
• Responsible for ensuring no document is re-opened or leads to non-conformity or observation due to lack of review against the defined procedure.
• Responsible for ensuring approved documents have no gaps, including compliance related to good documentation practices.
• Responsible for execution and approval of ISO 17025:2017 requirements at BGRC.

Behavioral Skills

• Good Interpersonal skills
• Self-time management
• Good Team player

• Polite/Good Communication skills

Syngene ValuesAll employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Specific requirements for this roleExperience

• 3-6 Years\' experience in Pharmaceutical Quality Assurance/Quality Control.

Skills and Capabilities:Candidate must be familiar with cGMP requirement, must have experience of handling analytical instruments and should be familiar with electronic platforms such as TrackWise, EDMS, LMS.Education

• B.Sc, M.Sc, B. Pharma, M.Pharma

Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, 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