Seeking - Analytical Development/Quality Assurance
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Dear Hiring Manager,
Myself Mr. Amey Ramkrishna Keer, I have completed my M. Pharmacy (Pharmaceutical Chemistry) at Bharati Vidyapeeth Deemed University, Poona College of Pharmacy, Pune. My last assignment was in Ciron Drugs and Pharmaceutical Pvt Ltd as a Manager – ADL Injectable, Ophthalmic / DQA. Additionally successfully completed Bachelor of Law (LLB) from Mumbai University with specialization in Intellectual Property Rights (IPR).
Throughout my 14+ years of career, I have maintained highest performance standard which is clearly illustrated by my past successes. With excellent 20 scientists Team leading and communication skill, an outstanding work ethic and the ability to work in both team-oriented and self-directed environment. I am positioned to exceed your expectations. I would welcome an opportunity to meet with you to discuss my qualification and candidacy in further detail.
Thank you for your time and consideration.
Company :Ciron Drugs and Pharmaceutical Pvt Ltd Company Profile :Pharmaceutical Industry
Location :Kopar khairane, Navi Mumbai
Department : ADL – Injectable, Ophthalmic/ DQA
Period : May 2023 to Dec 2025.
Worked as a Manager in ADL Department for Injectable project of simple and complex molecules, Ophthalmic products for regulated as well as ROW market with leading almost 20 scientist. Responsible for method development, Partial Validation, Handling regulatory deficiency for ROW and ANDA Project. Additionally responsible for Development Quality Assurance department for laboratory compliance. Additional support for Supplied Chain Management for procurement activity, DMF Review.
Expertise in handling method development skill for simple/complex Injectable and Ophthalmic projects in stipulated timeline.
Expertise in Handling cleaning Method development and cleaning validation activity.
Hands on experience for handling internal audits as well as Clients Audits with successfully providing compliance in stipulated time.
Review of Incident , Deviation, Risk assessment and evaluation documents.
Support for Plant audits for regulated and semi regulated market products.
Successfully developed and transferred more than 25 projects till date with more ongoing.
Company :Manisha Analytical Laboratory Pvt Ltd
Company Profile :Pharmaceutical Testing Laboratory
Location :Mira Road (East), Thane
Department :Quality Assurance/ADL(PTL) Period :Dec 2021 to April 2023
Job Profile: Working as an Quality Manger in Public Testing Laboratory (Method development, Method Validation, Biowaiver, Stability testing)USFDA registered, ISP Chile (Biowaiver Study) Approved site of Manisha Analytical Laboratory Pvt Ltd. Heading department like Quality Assurance and Validation and stability laboratory. Responsible for managing quality and data integrity to assure that the operational business in compliance with GxP requirements across all company sites Implementing and maintaining a Quality Risk Management system to ensure that risks are adequately controlled in accordance with current regulatory requirements and industry best practices.
Review of SOP , approval and revision of SOP/tracking of SOP record. Good knowledge of GDP,GLP guidelines and scope of their use to our unit. Troubleshooting
/response to client comments for satisfactory conclusion. Good knowledge about documentation related to commissioning and qualification. Preparation of URS deviation list. Risk assessment, risk mitigation. Client Support for site documentation requirements.
Post :Senior Research Associate(Team Leader)
Department :Analytical Research & Development Department Period :March 2018 to July 2021
Job Profile : Working as a Team leader-Handing 6 Scientist with Project lead experience, Associated with Internal Audit and compliance, Analytical Data Review for development, Validation, Looking over US Regulatory deficiency, Individual handling experience of different project. Addition responsibility for US Compendia update. Working experience in Auditable Lab. Additional support for Supplied Chain Management for procurement activity, DMF Review experience.
Department :Analytical Research & Development Department Period :November 2014 – March 2018
Job Profile :Working for US, Europe Projects for Solid and Semi Solid Dosage form Cream, Lotion including IVRT analysis also perform various analytical method developments on HPLC for Assay, related substance and Analytical data Review, Stability Data Compilation, Handling of Plant Query and Technology Transfer. Force degradation study for Assay and Related Substance.
Department :Analytical Research & Development Department Period :August 2013- March 2014
Job Profile : Working for ANDA Projects, Europe, including their various analytical method developments on HPLC, UV, their method for related substance and documentation. Preparation of method development report. Analysis of routine and stability samples.
Location :Vikhroli, Mumbai
Department :Analytical Development Department(Injectable) Period :October 2011 – July 2013
Job Profile : Analytical Method development for Injectable Liophilizer and dry powder Injectable formulation. Hands on experience on miscellaneous test like determination of ph, weight/ml, Osmolarity for Injectable formulation. Hands of experience of Hold time study for Injectable formulations. Execution of analytical method transfer. Handling of various formulation such as anticancer injection dosage form, dry powder for suspension , solid dosage form.
ExaminationName of InstituteName of UniversityYear of Passing%
Bachelor of Law (Specialization in IPR)Law college, RatnagiriMumbai University201858.00%M. Pharmacy (Pharmaceutical
Bharati Vidyapeeth, Poona College of Pharmacy,PuneBharati Vidyapeeth Deemed University, Pune. (Maharashtra)201169.14%B. PharmacyBharati Vidyapeeth College of Pharmacy, KolhapurShivaji University, Kolhapur200963.40%H.S.C.Gogate Jogalekar College, Ratnagiri.Kolhapur Board200561.00%S.S.CPhatak Highschool RatnagiriKolhapur Board200373.20%
