Title:  DMPK-QAC

Designation: QAC – Internal DMPK

Job Location: Bangalore

Department: Discovery Biology

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

Job Purpose

Responsible for understanding, learning & reviewing pre-clinical study reports and audit trails for all the user-specific instruments. Learn & perform live/ retrospective/ systems/ lab audits and ensure that team complies with all the SOPs and client requirements.

Key Responsibilities:

• Ensure compliance with Data integrity policy and identify the cause of non-compliance.
• Ensure compliance with the safety policy, procedures, and stated requirements and identify the cause of non-compliance.
• Responsible to review the in-vitro, in-vivo, and bio-analytical reports within the scheduled timeline.
• Ensure ALCOA+ principles for DMPK Lab in all the procedures, processes, and systems.
• Responsible to follow and implement the guidelines and principles related to in-vitro, in-vivo, and bio-analytical verticals in the DMPK lab.
• Responsible for Conducting Lab Audit, Live audit and regular audit trail checks for all the instruments related to user-specific login.
• Ensure the training and qualification of analysts working in the respective area of QC laboratory.
• Responsible to review eLN for traceability, auditability, integrity & compliance with Syngene’s SOP.
• Logbook control – ensure that all applicable log books are written legible. Maintained and controlled appropriately as per GDP.
• Responsible for Monitor and follow up of Instrument preventive maintenance and calibration records and overdue. 
• Investigation, provide inputs in the identification of root cause and to propose CAPA
• Good written and oral communication skills interacting with internal stakeholders

 TECHNICAL /FUNCTIONAL SKILL:

Should be familiar with Good Documentation Practice.

Should have exposure to various Regulatory audits

Educational Qualification: M. Pharma/ M.Sc.

Experience:

• Minimum 3 to 6 years of relevant experience

Behavioural Skills:   

• Good communication, technical report writing skills and E- Mail etiquette.
• Basic knowledge on Excel sheet and windows operations.
• Ability to meet tight deadlines and prioritize workloads.
• Should be able to work in team and flexible for working in shifts.

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