Manali Yashwant Parab
Assistant Manager Quality Assuarance
Thane
Summary
Hardworking Quality Assistant Assurance Manager with extensive knowledge of Pharmaceuticals (API and Final Product) and Medical Devices inspections to multitask effectively. Skilled at managing long-term quality goals and day-to-day organization. Successful at forecasting market trends and financial needs.
Also Worked as Associate Scientist for 2 years and 10 months in Analytical Research & Development.
Currently seeking responsible and challenging position with company where I can employ my knowledge to reach the objective of the organization.
Overview
3
3
years of professional experience
10
10
years of post-secondary education
2
2
Certifications
Work History
Assistant Manager Quality Manager
SMAform Engineering Pvt. Ltd
Dombivali
04.2022 - Current
- Implemented ISO 9000 quality systems and ISO 13485 for medical devices, defining business practices, leading to certification and better business practices.
- Team Management: Manages a team of 3 employees
- Customer Satisfaction and complaints: Tracked quality issues with external customers, suppliers and internal plant operations. Developed quality planning for multiple new product launches by verifying customer requirements and implementing in design and production.
- Literature Search: Carry out the literature search to understand the competitors’ products
- Supplier Management: Specified quality requirements of raw materials with suppliers.
- Stakeholder Management: Implemented new quality assurance and customer service standards.
- Logistic Related: Preparation of BOM (Bill of Materials). Estimated financial requirements of new projects.
- Cross Functional Team Management: Co-operated with engineering, manufacturing, packaging, purchase, sales and corporate accounting to verify adherence to quality standards.
- Training and performance improvement: Monitored staff organization and suggested improvements to daily functionality. Evaluated interactions between associates and customers to assess personnel performance.
- Audit activities: Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
- Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
Associate Expert
Novartis Healthcare Pvt. Ltd
Hyderabad
08.2019 - 04.2022
- Strategic Thinking: To carry out literature search for the existing analytical methods and determine the strategy for the method development,Presentation of Method Development Strategy Reports
- Investigations of deviations: To investigate and handle the deviations, perform Root Cause Analysis, Risk Assessment and provide CAPA
- Regulatory Reports Preparations: To prepare Drug Stability Reports, Registration Stability Reports, Method Validation Reports, Method Validation Protocols etc., and answering queries for health regulatory authorities’ submissions
- Presentation: To present Weekly Pharma Updates
- Presented the investigations in the global forum
- To perform Lean Lab activities and keep lab audit ready.
Education
Master of Pharmacy - Pharmaceutical Analysis
Bombay College of Pharmacy
01.2017 - 01.2019
Master of Pharmacy - Industrial Pharmacy
C.U. Shah College of Pharmacy
01.2016 - 01.2017
Bachelor of Pharmacy (B. Pharm -
Government College of Pharmacy, Mumbai University
04.2012 - 04.2016
HSC -
M.H. High School And Jr. College
01.2010 - 01.2012
SSC - Pharmacy (Pharmaceutical Analysis
M.H. High School And Jr. College
06.2009 - 01.2010
Skills
Document creation and document reviewData integrity review
Data extraction search from science direct, Orange Book
Good knowledge of MS Office MS-CIT) with Microsoft Office
Data trending with excel: Certification in Microsoft Excel by Udemy
Certification
Enrolled for PG diploma in Advanced course in GLOBAL REGULATORY AFFAIRS
Additional Information
- NCERT, Delhi (Exam Centre: , Pune) Pre-Secondary School Scholarship Examination scholarship holder (2004), exam held by Maharashtra State Examination Board
- Pune Silver Level qualified of HDFC Meritus Scholarship in 2009
Timeline
Assistant Manager Quality Manager
SMAform Engineering Pvt. Ltd
04.2022 - Current
Associate Expert
Novartis Healthcare Pvt. Ltd
08.2019 - 04.2022
Master of Pharmacy - Pharmaceutical Analysis
Bombay College of Pharmacy
01.2017 - 01.2019
Master of Pharmacy - Industrial Pharmacy
C.U. Shah College of Pharmacy
01.2016 - 01.2017
Bachelor of Pharmacy (B. Pharm -
Government College of Pharmacy, Mumbai University
04.2012 - 04.2016
HSC -
M.H. High School And Jr. College
01.2010 - 01.2012
SSC - Pharmacy (Pharmaceutical Analysis
M.H. High School And Jr. College
06.2009 - 01.2010