Supervisor Formulation Production

JOB DESCRIPTION

Job Title: Supervisor - Formulation Production

Job Location: Bangalore

Department: Pharmaceutical Development - FD

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:

Role Accountabilities

• Responsible for production and facility management of S18 FC OSD A1 FDC S15 Formulation for Early phase Late phase and Commercial operations.
• Overall adherence to safe practices and procedures of oneself and the teams aligned.
• Contributing to the development of procedures practices and systems that ensure safe operations and compliance to the companys integrity & quality standards.
• Driving a corporate culture that promotes environment health safety and sustainability (EHSS) mindset and operational discipline at the workplace at all times.
• Ensuring the safety of self teams and lab/plant by adhering to safety protocols and holding self and their teams accountable for the achievement of safety goals.
• Ensure all assigned mandatory trainings related to data integrity health and safety measures are completed on time.
• Documentation Management for Preparation and Review of the SOPs EOPs IOPs BMR/BPR documentation activity both manually and in Electronic Document Management System (EDMS) as an author reviewer or coordinator.
• Document management for Preparation and Review of URS DQ IQ OQ and PQ of equipments/ instruments etc. both manually and in Electronic Document Management System (EDMS) or Validator as an author or reviewer.

Experience: 6 to 10 Years - Oral solid dosage form and Liquid filling in hard gelatine capsules

Skills and Capabilities

• • To participate in periodic management review meetings self-inspections and internal quality audit.
  • To ensure and implement procedures to target Zero Incidents.
  • Supporting for Preparation and review of documents like but not limited to BMR/BPR/Protocol/Report etc related to S18 OSD
  • Strong leadership and hands on expertise in oral solid and liquid fille in hard gelatine hard gelatine capsules packaging and facility operations in compliance with cGMP.
  • In depth knowledge of QMS GDP data integrity and regulatory requirements with proven capability to review approve and drive SOPs protocols QRM study reports deviations change controls and CAPAs.
  • Extensive experience in equipment and facility lifecycle management encompassing installation commissioning FAT/SAT IQ/OQ/PQ periodic requalification and routine validation activities.
  • Strong cross functional coordination skills enabling effective collaboration with Engineering Validation Quality Assurance and other stakeholders for calibration preventive maintenance qualification and issue resolution.
  • Demonstrated capability in regulatory and customer audit management including inspection readiness audit trail oversight alarm trending review responses to observations and CAPA implementation.
  • Proven people management and development skills including training strategy mentoring performance oversight and fostering a strong GMP and safety culture within the manufacturing team.
  • Ability to drive continuous improvement risk management and operational excellence aligned with current regulatory expectations and business objectives.

Education : Masters or Bachelors degree in Pharmacy or a Masters degree in Pharmaceutical 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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.