Sterile Manufacturing & Filling supervisor
Sterile Manufacturing & Filling supervisor
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Job Title: Sterile Manufacturing Filling Supervisor
Department: Formulation production
Job Location:Bengaluru India
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:
Responsible for Injectable formulation Production activities.
Role Accountabilities
- Responsible for support to plan for manufacturing and packing of Injectable manufacturingfacility for small molecule formulations & large molecules (biologics) should have expertise in aseptic filling and sealing areas is mandatory.
- Responsible for ensuring compliance and management of QMS documentation like change control Deviation Investigations OOS OOT customer complaints validation protocols CAPA APQR Audit management etc. both manually and in electronic Quality management system (EQMS).
- Coordination with cross-functional departments for completion of production targets and support for achieving of production numbers for weekly monthly and annually.
- Responsible for facility planning to achieve monthly targets capacity utilization monitoring and upkeep for smooth functioning of production activities clinical batches and manufacturing/commercial batches. Responsible for approval of purchase orders for new instruments/equipment accessories and consumables for day-to-day functioning of the formulation unit.
- Coordination with other functions like project management HR Formulation and development regulatory QA and QC with respect to various plant-related activities for completion of production targets and support for achieving of production numbers of weekly monthly and annually. Ensuring monthly production targets are met as required by complying with applicable predetermined quality standards.
- Responsible for implementation of cGMP requirements to meet compliance w.r.t. USFDA EU and MHRA standards. Supported in the preparation of various client visits and regulatory and QP audits.
Syngene Values
All employees will consistently demonstrate alignment with our core values
- Excellence
- Integrity
- Professionalism
Experience
- 11-15years of relevant experience
Skills and Capabilities
- Team player Result oriented and focus.
Education
- Bachelor pharmacy / masters degree in pharmacy / in science
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:
Manager
Employment Type
Full Time
