Title: Junior Manager
Functional or Technical skills
JOB DESCRIPTION
Job Role : Analytical QA Analyst
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
Core Purpose of the Role:
• Responsible for review of all types of laboratory data which includes Raw material, Finished product, stability, method validations, method transfers, method verifications, calibrations, qualification documents.
• Responsible for review of change controls, deviations, incidents, OOS,OOT and to prepare the trend reports for all QMS
• Responsible for preparation and review of standard operating procedures.
• Ensuring all data to be maintained as per Good Documentation Practices.
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
• Attend training on environment, health, and safety (EHS) measures imparted company.
echnical/functional Skills:
Should have experience in Quality Control testing and review of laboratory data
• Hands on experience in handling of analytical instruments i.e. Karl Fischer (KF), Infrared Spectroscopy (IR), Differential Scanning Calorimetry (DSC), Thermogravimetric Analyzer (TGA), High-performance liquid chromatography (HPLC), Gas chromatography (GC), Ion chromatography (IC), Inductively coupled plasma mass spectrometry (ICP-MS), Inductively Coupled Plasma Optical Emission spectroscopy (ICP-OES) etc.
• Able to identify questionable, out of trend results during review process.
• Should have knowledge on regulatory guidelines, Pharmacopeia general chapters
Should have knowledge instrument and equipment qualifications which includes CSV activities
Behavioural Skills
- Good Interpersonal skills
- Self-time management
- Good team player
- Good communication skills
Syngene Values
All employees will consistently demonstrate alignment with our core values
• Excellence
• Integrity
• Professionalism
Specific requirements for this role
Experience
• 6 to 9 years
Education
• M. Pharm/ M. Tech/ M.Sc. / B.Tech., B.Sc. (Analytical chemistry/Chemistry) with 6 - 9 years
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.