Supervisor - Formulation Production

JOB DESCRIPTION

Job Title: Supervisor - Formulation Production

Job Location: Bangalore

Department: Pharmaceutical Development - FD

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

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 company’s 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 equipment’s/ instruments etc. both manually and in Electronic Document Management System (EDMS) or Validator as an author or reviewer.
• Support for FAT, evaluation of equipment risk assessment, assist in protocol preparation for Decommissioning of existing equipment’s and commissioning from at new and existing facilities.
• Support for entire plant area validations and qualifications to meet projected timelines.
• Support in facility planning to achieve weekly, and monthly targets, capacity utilization, monitoring and up keeping for smooth functioning of production activities, clinical batches manufacturing/commercial batches manufacturing.
• Supervision and review during batch manufacturing, packaging, calibration and other miscellaneous activities related to production
• Equipment setup, operation, dismantling and cleaning of manufacturing and packaging equipment and instruments.
• Daily log book entries, verification of equipment and instrument as applicable.
• Daily, weekly and monthly Instrument verification and calibrations.
• Training to operators on new equipment’s and instruments during installation.
• Raising indent for new accessories and change parts for day-to-day functioning of formulation production.
• Work allocation to operators in formulation production.
• Entries in batch records, protocols and relevant equipment usage log books.
• Coordination with the cross-functional department for the completion of production targets and support for achieving production numbers for weekly, monthly and annually.
• To monitor, control, handling of punch tooling and change parts for all equipment’s in the formulation production.
• Linen management - cleaning, storage and inventory of garments as per SOP.
• Perform identification, assessment and categorization of consumables.
• Management of QMS documentation like change controls, incidents, deviations, investigations, CAPA, OOS, OOT, customer complaint, Audit management, etc. both manually and in Electronic Quality Management System (EQMS).
• Consumables inventory management, procurement, receipt and verification of consumables during receipt.
• Coordination with engineering and maintenance team during preventive maintenance of equipment.
• Monitoring of environment monitoring system (EMS).
• Equipment, instrument and area cleaning record and checklist update.
• Complete online and offline trainings on time.
• Supporting for the department for audit preparation and monitoring.
• Support in implementation of cGMP requirements to meet compliance w.r.t. USFDA, EU, MHRA standards.
• Support in preparation of various client visits, regulatory and QP audits.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Experience: 5 to 10 Year’s - 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 : Master’s or Bachelor’s degree in Pharmacy, or a Master’s 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 law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.