IPQA Drug Specialist
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Job Location:
Monthly Salary:
Posted on:
23-10-2025
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION
Job Title: IPQA Drug Specialist
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 integrityhealth 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:
- Line Clearance process overview Product change over.
- Timely area readiness (Cleaning EMS OOS status) and ensures availability of documents and material status.
- Monitoring of process through process step verification.
- Reviewal of Batch Manufacturing Record to check compliance from stepwise process execution till written instructions.
- Equipment / utility Qualifications Calibrations PM verification.
- Utility / Computer system validation
- Process validation and cleaning validation.
- Target Monitoring for batch related process activities.
- cGMP compliance and verification overview of BMP facility & Utilities.
- SOP preparation and review.
- Training
- GEMBA principles
- Quality management system investigation.
Role Accountabilities
- Anytime audit readiness
- Timely area readiness (Cleaning EMS OOS status) and ensures availability of documents and material status for manufacturing.
- Utility & Manufacturing area and document compliance.
- Equipment / utility Qualifications Calibrations PM verification.
Syngene Values
All employees will consistently demonstrate alignment with our core values
- Excellence
- Integrity
- Professionalism
Specific requirements for this role
- Experience 6-9 years
- Demonstrated Capability Process QA Manufacturing compliance.
- Education MSc
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:
IC
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About Company
We are an innovation-led contract research, development and manufacturing organization offering end-to-end solutions to fulfil R&D and manufacturing requirements of our clients
