Tausif Khan
Central Islip,NY
Summary
Seeking a reliable and conscientious position within an organization that will utilize my MANAGEMENT, SUPERVISION & INTERPERSONAL skill to benefit mutual growth and success. Reviewing in-process and finish good batch records, performing label approval, release of in-process martial, inspect finish product to ensure conformance to specifications. Professional having experience as a Regulatory affairs Specialist, process development, experienced in Quality Assurance, change controls, Deviations, regulatory submissions and Post Market Surveillance activities and process optimization developing and implementing regulatory strategies for compliance with FDA regulations and CMC requirements. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
15
15
years of professional experience
Work History
REGULARITY SPECIALIST/INTERNATIONAL REGISTRATION
NESTLE HEALTH SCIENCE
01.2023 - Current
- Responsible for providing all regulatory support to Consultants and Distributors in export Countries, to assure compliance wit local regulatory legislation, and Company's requirement
- Perform regulatory documents and provide those to consultants and distributors- Technical and legal documents of registration and certificate of foreign government, certificate of Free Sale, Good Manufacturing, etc
- Develops label manuscripts containing all information that is permitted to appear on product labels and proofreads product labels for accuracy and conformity
- Using code of Federal Regulation (CFR) and other applicable regulation, ensure label manuscripts and proofs are prepared in compliance
- Develops complete product documentation including information to substantiate labeling such as formulation, raw material data vendors, and appropriate product warning
- Coordinates individual deliverable with departmental and business objectives
- Complete checklists and other procedural documentation
- Prepared documentation in support of regulatory filling and submission on the US and EU
- Prepared of high quality pre and post market submissions for global markets and works with Regional Operating Units to obtain and maintain global product regulatory documentation, approvals, and product renewals
- Prepared, reviewed, and approved regulatory submissions (FDA) to ensure compliance with applicable regulations and guidance.
- Oversaw daily operations of a busy office environment, ensuring tasks were completed efficiently and accurately.
- Followed all company policies and procedures to deliver quality work.
REGULATORY AFFAIRS ASSOCIATE
SPIRIT PHARMACEUTICALS
10.2021 - 12.2022
- Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in high-volume environment with shifting priorities
- Time management, organization and planning skills, and multi-tasking and prioritization skills in fast-paced environment
- Ability to maintain high level of accuracy and attention to detail, while meeting deadlines for assigned projects
- Excellent written and verbal communication skills and interpersonal skills
- Ability to communicate effectively and collaboratively as part of team in respectful manner
- Ability to work independently.
- Supported global product registrations by liaising with international partners and assisting with local regulatory requirements.
- Coordinated responses to FDA deficiency letters, addressing concerns promptly and professionally while minimizing disruption to ongoing projects.
- Maintained open lines of communication with FDA representatives throughout submissions processes, fostering positive relationships that contributed to expedited approvals.
- Conducted thorough reviews of labeling content for accuracy and adherence to relevant regulations before submission to authorities.
DOCUMENT REVIEW SPECIALIST
PIPING ROCK HEALTH PRODUCTS
03.2020 - 10.2021
- Perform final review of manufacturing documentation and provide support in area of compliance for batch release
- Provide lot status updates as requested
- Perform and/or support final release of batch records
- Document and submit reports and documentation errors to management, for trend and training analysis
- Provide support to Compliance and investigation groups, Quality Assurance-manufacturing floor groups during real time reviews and assist other departments with batch retrieval and filling
- Adheres to all applicable local procedures, cGMPs, company policies, as well as other quality or regulatory requirements (OSHA, DEA, FDA, HS&E, etc.)
- Ensures all work is performed in safe, effective manner, and in compliance with appropriate procedures
- Other duties as deemed necessary.
- Enhanced document review efficiency by streamlining processes and implementing new organizational strategies.
QUALITY INSPECTOR
PIPING ROCK HEALTH PRODUCT
10.2019 - 03.2020
- Reviewing batch records and ensuring compliance to associated procedure
- Documentation, specification, and another regulatory requirement
- Verifying and documenting lot of information including manufacturing and expiration dating
- Perform label approvals for correct revision and content
- Performing inspections for outgoing material
- Communicating inspection failures, deviations, and non-conformances to QA Management
- Understanding and following written instructions provided in company procedures and specification
- Assisting in ensuring compliance to cGMPs and company polices/procedure
- Assisting in communicating and interacting effectively with packaging and production personnel
- Assisting in updating procedures and SOP's to reflect current practices and requirements
- Performing other related duties as assigned.
- Developed and maintained comprehensive documentation for quality control procedures, increasing efficiency and transparency.
- Enhanced product quality by conducting thorough inspections and identifying areas for improvement.
ASSISTANT MANAGER
7 ELEVEN. INC
06.2013 - 10.2019
- Performed supervisory actions such as training and coaching employees in providing excellent customer services experience, opening/ closing store operation, scheduling employees work hours, ensuring efficient customer services
- Also forecasting, ordering, stocking merchandise.
- Improved customer satisfaction by addressing and resolving complaints promptly.
- Developed strong working relationships with staff, fostering positive work environment.
PHARMACY TECH-CVC/PHARMACY
CVS Pharmacy
02.2009 - 06.2013
- Provided high level of customer services by helping customers with all their questions meanwhile managing multiple tasks such as counting, labeling, filling prescription drugs, restocking shelves and checking inventory.
- Managed multiple tasks simultaneously while maintaining high levels of accuracy and efficiency.
- Spearheaded initiatives designed to improve workflow processes within organization.
Education
Associate of Arts - Business Administration
Plaza College
Forest Hills, NY06.2011
High School Diploma -
WILLIAM CULLEN BRYANT HIGH SCHOOL NY
Astoria, NY05.2009
Skills
- Excellent verbal and written communication skills
- Quick learner; possessing initiative and troubleshooting ability
- Capable of collaborating and building working relationships internal and external to QA department
- Highly proficient in MS Word
- Proficient on MS Excel and Outlook
- Strong team player: open to assisting with any task in order to get work completed
- Strong organizational skills: demonstrated ability to manage multiple tasks simultaneously and ability to react to shifting priorities to meet business need
- Professional and punctual
- CGMP
- Expert Problem Solving
- FDA
- METADATA
- Documentation Management
- Quality Assessment
Languages
English
Native or Bilingual
Hindi
Native or Bilingual
Urdu
Native or Bilingual
Spanish
Limited Working
Timeline
REGULARITY SPECIALIST/INTERNATIONAL REGISTRATION
NESTLE HEALTH SCIENCE
01.2023 - Current
REGULATORY AFFAIRS ASSOCIATE
SPIRIT PHARMACEUTICALS
10.2021 - 12.2022
DOCUMENT REVIEW SPECIALIST
PIPING ROCK HEALTH PRODUCTS
03.2020 - 10.2021
QUALITY INSPECTOR
PIPING ROCK HEALTH PRODUCT
10.2019 - 03.2020
ASSISTANT MANAGER
7 ELEVEN. INC
06.2013 - 10.2019
PHARMACY TECH-CVC/PHARMACY
CVS Pharmacy
02.2009 - 06.2013
Associate of Arts - Business Administration
Plaza College
High School Diploma -
WILLIAM CULLEN BRYANT HIGH SCHOOL NY
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