Assistant Manager

Job Description

• 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) for small volume parenteral and sterility assurance qualification such as media fill, leak test, steam sterilization, terminal sterilization etc.
• Support for FAT, evaluation of equipment risk assessment, assist in protocol preparation for small volume parenteral and sterility assurance qualification such as media fill, leak test, steam sterilization, terminal sterilization etc.
• Support for entire plant Area validations, Qualification to meet projected timelines.
• Support in facility planning to achieve weekly, monthly targets, capacity utilization, monitor and up keeping for smooth functioning of production activities, clinical batches manufacturing/commercial batches manufacturing.
• Documentation Management for Preparation and Review of the SOPs, EOPs, IOPs., BMR/BPR and other documentation activity by both manually and in electronic document management system (EDMS) as an author or reviewer or coordinator.
• Managing production team involved in day to day operations of parenteral products.
• Responsible for support to plan for manufacturing and packing of Injectable manufacturing facility for small molecules formulations & large molecules (biologics) products.
• Support for parenteral formulations technology and manufacturing of clinical supplies.
• Supervision of Vial filling line for liquids and lyophilized products, PFS filling line and Cartridge filling line.
• Perform transfer of technology from development scale to pilot scale for parenteral formulations.
• 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) as per need.
• Responsible to monitor WFI generation and distribution management and to ensure smooth functioning of entire system.
• Training to Technicians on new equipment s and instruments during installation.
• Raising indent for new instruments /equipment s/ new accessories for day to day functioning of formulation development center.
• Work allocation to technicians in formulation production.
• Entries in batch records, protocols, relevant equipment usage log books.
• Co-ordination with cross functional department for completion of production targets and support for achieving of production numbers for weekly, monthly and annually.
• Co-ordination with engineering and maintenance team during preventive maintenance of equipment.
• Daily monitoring of environment monitoring system.
• Equipment, Instrument and area cleaning record and checklist update.
• Complete online and offline training on time.
• Supporting for 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.
Secondary Responsibilities:
• To ensure and implement procedures to target Zero Incidents.
• To ensure proper Housekeeping.
• Facility readiness during audit/visit.
Quality Compliance Compliance and Adherence to all applicable Syngene Quality Systems. EHSS Compliance Compliance to Syngene EHSS Policies and Systems. 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.,

Keyskills :
salesdocument management systemaccountsbankingcontinuous improvement facilitationtatanimal healthmis