Injectable Fill finish (QMS and Mfg.)

Syngene International Limited

Job Title: Injectable Fill Finish Expert (QMS and Mfg.)

Department: Formulation production

Job Location: Bengaluru, India

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 Quality Systems of Injectable formulation Production activities.

Role Accountabilities

• Responsible for support to plan for manufacturing and packing of Injectable manufacturing facility for small molecule formulations & large molecules (biologics) products. He 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

• 11-15 years of relevant experience

Skills and Capabilities

• Team player, Result oriented and focus.

Education

• Bachelor pharmacy / master’s degree in pharmacy / 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 law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

• Responsible for support to plan for manufacturing and packing of Injectable manufacturing facility for small molecule formulations & large molecules (biologics) products. He 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.