Associate DPP Manufacturing Operations

JOB DESCRIPTION

Job Title: Associate - DP Manufacturing Operations

Job Location: Bangalore

Department: Formulation Development

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 DPP1 facility manufacturing activities (operation and cleaning of vial washing, tunnel, vial filling & stoppering, vial sealing, O’RABS, Online particle counter, Offline particle counter, autoclave, compounding vessels, filtration vessels, pass-boxes, filter integrity machines, LAFs, bag sealing machine, weighing balances, unit preparation activities, verification of area cleaning and sanitization).

- Assist the validations/study and routine validations/study of equipment and facility. • Preparation of material requisition

- Dispensing of raw materials, primary packing materials, consumable materials and general consumable materials.

- Transfer of dispensed materials to the respective area.

- Requisition of GMP documents and completed documents submission.

- Performing pre and post batch manufacturing activities

Role Accountabilities

- Executing/Assisting the IQ, OQ, PQ related to equipment’s in drug product facility.

- Assisting in the validation of equipment and facilities.

- Identify and implement the manufacturing procedures with compliance to current GMP requirements.

- Co-ordination with product manufacturing activities and ensure GXP compliance in product manufacturing activities.

- Making the facility ready for various customer audits and regulatory audits.

- To maintain and review the audit trail, user privileges and alarms trending of critical equipment’s as and when required. • Completion of SAP related transactions (as applicable) related to functional work.

Safety and DI Responsibilities:

- Adhere to organizational policies & procedures on EHSS, POSH, Data Integrity and IT security, and monitor & confirm the same for the reports.

- Always wear the applicable PPEs and adhere to any other Environment, Health, and Safety (EHS) requirements in the workplace for individuals & lab/plant safety and monitor & confirm the same for the reports.

- Understand all necessary safety protocols and always follow the same to ensure safety for all and monitor & confirm the same for the reports.

- Proactively identify near-misses & potential incidents and communicate the same to supervisor and/or line manager or through the respective portals and disseminate learnings from those to the team members & any other concerned personnel to prevent recurrence of such events.

Specific Responsibilities:

- Ensure all general consumables are in place for regular activities.

- Verification of waste removal from the area.

- Verification of general area cleaning and sanitization

Syngene Values

All employees will consistently demonstrate alignment with our core values

- Excellence

- Integrity

- Professionalism

Specific requirements for this role

- Experience: 0 to 1

- Demonstrated Capability: Ensuring drug product manufacturing activities, ensuring GMP compliance, on-time batch execution, and adherence to quality standards.

- Education: B.Sc. / M.Sc. (Chemistry, Biotechnology, Microbiology, Life Sciences)

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.