Manager - Validation (Sterile)

5 hours ago

Nalagarh Himachal Pradesh India, Himachal Pradesh Immacule Lifesciences Full time

About the Company


Founded in 2012, today, Immacule Lifesciences has become a renowned name in the pharmaceutical industry. At Immacule, our dedicated team of scientists is here to provide you with customized services, supported by our extensive network of capabilities and resources. No matter where you are, as an end-to-end pharmaceutical service provider and partner we offer quality, speed and value by combining our technical competencies and cost-effective solutions.


We are backward integrated in pharmaceutical research and development and our focus ranges from the classification and development, to the commercialization of complex liquid (aqueous/non aqueous) and lyophilized injectables in vials and ampoules, with robust capabilities for terminal sterilization as well as aseptically filled injectables.


As a CDMO we are rapidly capturing the highly competitive sterile US market, in collaboration with our partners we have received 37 ANDAs approvals, have 18 ANDAs under review and a filing target of 50+ by 2025.


Immacule is focusing on First to File 505(b)(2) submissions, NCEs & complex generics niche products scale-up, exhibit batches & commercial manufacturing support services to its global clients.



About the Role



Responsible for Execution of equipment & utility qualification, requalification and other validation activities in plant as per validation planner.



Responsibilities


  • Responsible for maintaining the validation documents and validation planner.
  • Preparation of Standard Operating procedure related to Qualification.
  • Preparation of protocol, execution and compilation of aseptic process simulation report.
  • Responsible for preparation review, approval and control of effective documents.
  • To ensure compliance of GDP and data integrity techniques.
  • To follow EHS policies.
  • Responsible for Online activities in ERP, LMS, EQMS, LIMS, and EDCS, Caliber BMR as per requirement.
  • Responsible for initiation/ closure of Quality Management System (QMS) related documents: Change Control, Deviation, Incident, and CAPA in EQMS as per requirement.
  • Co –ordination with cross functional team and external party to execute the validation activities.
  • To handle the QMS activities related to qualification and validation.
  • Responsible to impart the training and department training coordinator activity.
  • Responsible for aseptic assurance.
  • Media fill protocol preparation review and approval.
  • Smoke study protocol preparation, review and approval.


Qualifications


B. Pharma, M. Pharma


Experience


12-16 Years of in sterile manufacturing facility

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