Quality Control Senior Manager

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.

Responsibilities

• Responsible for overall activities performed in the Quality Control Department.
• Implementing and monitoring of cGLP norms in the Quality Control Department.
• Responsible for internal / Customer / Regulatory Audits and Preparation of Reports.
• Implementation, Compliance and Maintenance of Quality Control SOPs.
• Responsible for Document Management System for Raw Material, In-Process Samples, Packing Material, Finished Product and Stability Samples.
• Managing Deviations, Change Control, Incidences with Investigations and associated CAPA.
• Investigation of OOS, OOT & OOE in the Quality Control Department and associated CAPA.
• To review and approve the Validation / Qualification protocol and report of the equipment installed in the Quality Control Department.
• Arrangements of Analytical Method Transfer, Analytical Method Validation of Chemical and Micro sections.
• Accomplishing QC Human Resources objectives by Recurring, Selecting, Training, assigning, counseling and discipline employees.
• Meet QC financial objectives by estimating requirements.
• Involving in self inspection, CFT meeting and functional review meeting.
• Achieving QC operational objectives by contributing information and analysis to strategic plans and review.
• Review and approval of analytical documents w.R.T. Data Integrity.
• Release / reject of Raw Materials, Packing Materials, Stability, In-Process and Finished Products.
• To impart trainings to the subordinated and participate in the training programs organized by the company.
• To ensure that prescribed safety precautions are being taken by the subordinates while performing analysis.

Qualifications

M.Sc / M.Pharma in Chemistry

Preferred Skills

18+ Years experience in sterile facility