Amey Keer

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

Post                    : Manager

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

Post           :Quality Manager

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.

The Key Result Areas:

•  Lead Quality Assurance and AD department with experience in handling clients audit, FDA Audits.
• Experience of preparation of Audit response and compliance in stipulated time line.
• Preparing site for USFDA, Uganda, Europe and Australian Market.
•  Experience in handling multiple local FDA audit and successfully provided compliance in stipulated time.
•  Additional experience in Technology marketing, different client communication and quotation negotiation skills.
• Conducting internal lab audit and assurance of compliances for the same.
• Review of Quality management system like change control, incident and deviation, Trending  and evaluation of the same.
• Review of Analytical Method Validation protocol ,method transfer protocol.
• Experience of Handling full Biowaiver study for multiple project for ISP Chile.
• Excellent Knowledge about method development and validation of Nitrosamine Impurities by LC-MS/MS for API as well as Finished dosage form.

Company            :Par Formulation Pvt Ltd Company Profile :Endo International group Location             :Digha, Navi Mumbai

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.

The Key Result Areas:

• Team leading for Analytical Method development for different formulation like

Injectable, Solid oral, Ophthalmic for US market.

• Team lead for completion of 4 Project including Method development, routine  support and validation support.
• Hands on experience on master control (21CFR)compliance software for Method, protocol and report preparation.
• Handling USFDA regulatory deficiency for almost 2 Projects.
• Prepared and finalized almost 4 Product Specifications for Drug Products.
• Reviewed almost 4project analytical method development report.
• Review of various STP for drug products and approval.
• Additional taking responsibility for API vendor Evaluation activity.
• Conducting  Internal lab audit and assurance of compliances for the same.
• Review of Quality management system like change control, incident and deviation.
• Review of Analytical Method Validation protocol, method transfer protocol
• Excellent presentation skill and experience skill for handling regulatory deficiency and method equivalency.
• Review of SOPs, IOPs for various procedures and instruments.
• Additionally working for Regular USP Compendia updatation and implementation in Lab.
• Experience for facing US-FDA Audit at Par Formulation Rabale Site, Navi Mumbai.
• Preparation of  SOP &Validated Excel for Assay, Dissolution & Related Substance.
• Knowledge about Computer System Validation for HPLC and UPLC.

Company          :Glenmark Pharmaceutical Ltd Location                          :Taloja, Navi Mumbai

Post                   :Research Officer

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.

The Key Result Areas:

• Analytical  method  development  & part validation i.e. rigorous testing of methods to ensure they are precise, accurate, reproducible, "fool-proof"& specific to the product.
• IVRT method development for Lotion and Cream.
• Preparation of summary report for all new developed methods.
• Troubleshooting  and cost effective development of new analytical methods
• Supporting Regulatory affairs department with respect to analytical data required for submission.

Company          :Ipca Laboratory Ltd Location                   :Kandivali, Mumbai Post                     :Research Associate

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.

Company                      :Cipla Ltd 

Location                :Vikhroli, Mumbai

Post                   :Management Staff

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.