Sr. Officer - ADL - Documentation with Globally 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: Globally Preferred CDMO Partner for Derma

• Position: Officer / Sr. Officer - ADL Documentation

• Markets: Global Markets

• Products: Topical & Ophthalmic

• Department:

  ADL Documentation

• Location: Mumbai

Job Profile:

• To support the Analytical Development Laboratory by managing and maintaining all documentation related to Analytical Method Development, Analytical Method Validation, & Analytical Method Transfer, Stability Studies and regulatory submissions in compliance with cGMP, GLP, and regulatory standards.
• Prepare Method Development, Method Validation & Method Verification reports & protocols for different analytical and microbiological tests of API, Excipients and finished product.
• To prepare Method transfer protocol for finished product to initiate the method transfer activity.
• To prepare and revise Standard Operating Procedure, Format and Annexure as per requirement.
• Preparation of documents like finished product specifications for In-process, Release and Stability testing, specifications for Raw material & Packaging material.
• Preparation of Standard test procedures as per Pharmacopeial monograph and vendor in-house methods for API and Excipients, In-House developed methods for finished products.
• Prepare Certificate of analysis for API and Finished product.
• Preparation of tentative STP
• Pre-Review and preside input on the final STP/ Specification.
• To identify the changes as per current Pharmacopeia updation and raise the change control to revise specifications and STP for API, excipient and finished product.
• Execution of method development audit such as rational experimental ratios, & Force degradation.
• Co-ordinate with cross functional teams at R&D, Rabale / Kandla plant, vendor, external lab, consultant etc. as and when required.
• Follow strict adherence to Good Documentation Practices.

Desired Profile:

• B.Pharm / M.Pharm / M.Sc (Chemistry / Pharmaceutical Analysis) with 2 to 5 years of experience in ADL Documentation in a reputed pharma formulation company.
• Candidates preferred from pharmaceutical industry, Specifically from R&D Set-up.
• Exposure in review of protocols & reports of analytical method validation, verification & method transfer activities.
• Excellent documentation and analytical review skills.
• Strong understanding of analytical development processes.
• Proficient in technical documentation review and QA systems.
• Good Documentation Practices, Good Laboratory Practices & Data Integrity.
• Familiarity with HPLC, GC, Dissolution, UV, and other analytical instruments documentation.
• Knowledge of ICH, cGMP, GLP, and regulatory guidelines.
• Exposure in Topical dosage form would be added advantage.
• Strong attention to detail and accuracy.
• Good coordination, communication, & problem-solving abilities.
• Good problem-solving, analytical thinking, and team collaboration skills.
• Excellent communication and coordination abilities.
• Good organizational and time management skills.

Recruiter's Contact Details:

BEST-FIT Recruitment Riders

G-7, Amrit Complex, R.V. Desai Road,

Near Goyagate Circle, Vadodara-390001, Gujarat

Mobile: 09722042906

E-Mail: post@bfrr.in

Website: www.bestfitrecruitment.co.in