Title:  Assistant Manager

Date:  10 Jul 2024
Job Location:  Bangalore
Pay Grade:  8-II
Year of Experience:  9 - 12 Years

JOB DESCRIPTION

 

Job Role: Assistant Manager- QA
Department: Quality Assurance - BGRC

Job Location: Bangalore

 

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 

 

Role Accountabilities:

  • Preparation and review of SOP for quality assurance and ensuring the timely revision of the same.
  • Review and approval of blank ODS, issuance of the copy from master ODS for lab execution and reconciliation of analytical package after completion.
  •  Issuance and withdrawal of logbook, SOP, IOP, EOP, GP etc. and annexures wherever applicable and maintenance of issuance/ withdrawal records.
  • Monitoring the usage of current approved procedures in all relevant departments.
  •  To ensure compliance with cGMP as laid down in the procedures.
  •  Monitoring changes implemented in compliance to cGMP.
  • Review of qualification protocols and reports.
  • Deriving (wherever applicable) and monitoring of CAPA implemented for its effectiveness.
  • Providing information to reporting manager regarding investigation to arrive at a decision for deriving CAPA.
  • Monitoring revision of specifications and test methods to ensure compliance with statutory and company standards.
  •  Preparation and review of trends/data bank of different types of non-conformities.
  • Monitor the investigation in case of excursion/breakdown of stability chambers/incubators.
  • Issuance and review of annexures related to the calibration of instruments and equipment whenever and wherever applicable.
  • Ensuring training and/or re-training on current procedures and general topics to relevant personnel in timely manner.
  • Review and approval of the QMS including deviation, incidents, Change Control, OOC, OOS, OOT, OOL and CAPA etc.
  • Review and approval of the documents such as RSMS, Protocols, Reports, SOP, IOP, EOP or any other documents assigned.
  •  Any other assignment allocated by reporting manager and/or above.
  • Review and approval of supplier evaluations.
  • Responsible for ensuring safe operations within BGRC QA, and accordingly to ensure zero safety incidents. Ensure to report safety incidents/near miss if any.
  • Ensuring laboratory activities meeting cGLP requirements and safety compliance by conducting the lab rounds and self-Inspections.
  • Attend for safety trainings as per the schedules.
  • Responsible for reviewing the documents as per relevant procedures and ensuring compliance.
  • Responsible for reviewing the documents as per relevant procedures and ensuring compliance.
  • To escalate the abnormalities/gaps in procedures if any, to reporting manager/ HOD or user department (where applicable).
  • To ensure no document is re-opened or leads to non-conformity or observation due to lack of review against the defined procedure.
  • To ensure approved documents have no gaps, including compliance related to good documentation practices.
  •  Responsible to ensure requirements of ISO 17025:2017 at BGRC (where applicable).

 

Behavioral Skills

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

•    Polite/Good Communication skills

 

Syngene Values

All employees will consistently demonstrate alignment with our core values

•     Excellence
•     Integrity
•     Professionalism

Specific requirements for this role

Experience

  • 9-12 Years’ experience in Pharmaceutical Quality Assurance/Quality Control.
  • Experience in handling of analytical instruments and documents review will be an added advantage.

Skills and Capabilities:

  • The candidate should be familiar with electronic platforms like LIMS, LMS, EDMS, TRACKWISE etc.

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.