Sr. Officer - IVRT R&D - Globally Preferred CDMO Partner For Derma

Greetings! & very warm welcome to BEST-FIT Recruitment Riders,

highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors.

professional career opportunity

Please see the following position summary:

• Client Name:

  CDMO Partner for Ophthalmic & Derma products for global markets.

• Position: Officer / Sr. Officer - IVRT R&D

• Markets: USA, Canada & ROW

• Products: Topical Formulations & Ophthalmic Preparations

• Location: Mumbai

Job Profile:

• To carry out analysis as per work planning or based on the organizational requirement.
• To follow and perform all required activities in IVRT department as per Standard Operating Procedure (SOP).
• To follow and maintain quality service in IVRT department by enforcing periodical Quality Management system i.e. Good Laboratory Practices, Good Documentation Practices etc., while working.
• To perform operation and calibration of instruments and equipments as per respective SOP of instrument and equipment.
• To co-ordinate and support for work wherever applicable with the internal department of R&D centre, visitor, external vendors etc.
• To perform IVRT method development, IVRT method validation and IVRT comparison study, Analytical method development, method validation and method transfer for the project assigned by team lead / Management.
• To execute and complete the project work related to IVRT analysis within stipulated timeline as per organizational requirement.
• To prepare and review documents like Standard Operating Procedure, protocols and reports etc. related to IVRT Department.
• To be involve in preparation and review of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) documents (wherever applicable) for the instruments and equipments which is to be install in IVRT department.
• To attend the training but not limited to SOP, protocol training, safety training organized by internal department of R&D centre or external party.
• To follow all safety precautions while working in IVRT department and other departments of R&D centre.
• To upkeep of IVRT laboratory for all time audit readiness and to participate in audit work wherever required as per organizational requirement.
• To support in training and involve in analyst qualification work for the new joined employee in IVRT department.
• To follow all rules and regulations set up by the organization during work tenure.

Desired Profile:

• M.Sc / M.Pharm (Pharmaceutical / Pharmaceutical Analysis / related discipline) with 4 to 6 years of experience in IVRT R&D for Regulated markets especially for topical and ophthalmic preparations to the pharmaceutical industries.
• Prior experience in IVRT method development and validation is essential.
• Familiarity with USFDA, Health Canada & ROW guidelines for topical dosage forms & Ophthalmic Preparations.
• Must have good experience in IVRT R&D as per SOP.
• Ensure Good Laboratory & Good Documentation Practices in IVRT department.
• Expertise to perform IVRT method development, IVRT method validation
• Should have experienced to prepare & review documents related to IVRT department.
• Good knowledge of preparation & review documents of Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) documents in IVRT department.
• Must have good Audit experience in IVRT laboratory.
• Strong documentation, technical writing, and regulatory compliance knowledge.
• Good problem-solving, analytical thinking, and team collaboration skills.

Recruiter Details:

BEST - FIT Recruitment Riders

G-7, Amrit Complex,

Opp: Mahavir Jain Vidhyalaya & Jain Derasar,

R.V. Desai Road, Near Goyagate Circle,

Vadodara-390001, Gujarat, India

Mobile: 09722052906, 09722042906

E-Mail: career@bfrr.in

Website: www.bestfitrecruitment.co.in