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Associate General Manager - Injectable Manufacturing

16.00 to 0.00 Years   Chennai   12 Oct, 2021
Syngene International Limited
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Role- Injectable Manufacturing headDepartment: Formulation DevelopmentJob location : BangaloreRole Purpose:The purpose of this role is to handle complete formulation parenteral injectable manufacturing & packing; to provide strategic direction in the above areas for both small and large molecules products.KEY RESPONSIBILITIES:

  • Should have experience for manufacturing of Parenteral formulations technology and support for manufacturing of clinical supplies.
  • Effectively manage the manufacturing activities & resources for smooth functioning and ensure that facility is in state of compliance with cGMP requirements
  • Should have hands on experience for operation of Vial filling line for liquids and lyophilized products, PFS filling line and Cartridge filling line.
  • Should have knowledge and experience for transfer of technology from development scale to pilot scale.
  • Implementation of documentation systems such as Standard operating systems, operational & Equipment operating procedures, BMR, BPRs.
  • To ensure training and good clean room practices according to the regulatory guidance.
  • Having experience on WFI generation & distribution system and guide the team.
  • To comply with EHS procedures, various statutory & regulatory guidelines.
  • Co-ordinate with other functions like project management, HR, Formulation Development, Regulatory, QA & QC with respect to various plant related activities.
  • To ensure facility operation within the laid down annual revenue budgets.
  • To ensure monthly production targets are met as per requirement by complying to predetermined quality standards, as applicable.
EDUCATIONAL QUALIFICATION:
  • B Pharm or M. Pharm qualifications.
WORK EXPERIENCE:Minimum 16 years in managing parenteral formulations.TECHNICAL /FUNCTIONAL SKILL:
  • Should have faced regulatory inspection like USFDA, EU GMP, MHRA etc.
  • Should have hands of expertise in qualification activities like URS, FAT, DQ, IQ, OQ, PQ of equipment/instrument for small volume parenteral and sterility assurance qualification such as media fill, leak test, steam sterilization, terminal sterilization etc.
  • Responsible for ensuring compliance of QMS activities like change control, Deviation, Investigations, OOS, OOT, market complaints, validation protocols, CAPA, APQR as per need.
BEHAVIORAL/MANAGERIAL SKILLS:
  • Good communication and presentation skills.
  • Good Leadership skills.
  • Good interpersonal skills.
  • Ability to demonstrate high degree of integrity and professionalism.
OTHER JOB REQUIREMENTS:
  • Participate in periodic management review meetings, self-inspections/internal audits/client and or regulatory audits.
  • Budget planning and ensure operations as per planned budget
,

Keyskills :
salesmarketingbusiness developmentmanagementretailcontinuous improvement facilitationchange controloperating systemsquality standardsmarket complaints

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