QA Complaint Specialist
Resume:
Gurpreet Grewal
**** ******** **, *********, **-*0083
********@*****.***
1
SUMMARY:
Self-Motivated Healthcare professional with 7+ years of experience in Quality & Operations and 15+ years of experience in highly regulated healthcare industry.
Customer focused, Detail oriented with critical thinking and problem solving attitude (simplifying the complex).
Highly organized and effectively work in cross-functional environment and recognized by peers as strong individual contributor.
Possess effective technical writing skill set.
Always looking for an opportunity to learn new things, expand knowledge-base, and to enhance mindset from new experiences.
OBJECTIVE: To expand my career in a challenging position that will utilize my skills and enhance existing experience as Quality professional.
EXPERIENCE:
Quality Assurance Complaint Specialist at Fresenius Kabi: Sept 2018 to Present o Achieved excellence in Operations Quality and Compliance by managing organization CAPA, Complaints, Field Alert Rationales (FARC), Field Alerts and Change Control metrics and presenting during the management reviews. o Serving as SME for Medicinal product customer complaints investigations, collaborate cross functionally with Medical affairs and Contract manufactures. o Developed and maintained Quality Contracts of Third-Party Distributors and Suppliers. o Supports internal and external regulatory agency audits. o Assists in the review and revision of standard operating procedures as needed. o Perform batch record reviews for Third Party products and Contract Manufacturers. o Supported Global Process Improvement initiatives for complaints, batch record review and FARC processes.
Quality Assurance and Operations Partner II at AbbVie: July’ 2013 to Sept’ 2018, Contract Employee CorTech Consulting -CPht -Pharmacy Solutions an AbbVie Company Sep’12 to July’13:
o Worked with quality assurance to get an approval for clinical study site (contracts, reviewing HCP CVs).
o Represented QA-Operations during different phases of product development and lifecycle management process for drug delivery system. o Successfully participated in the effort of establishing problem codes (during design transfer phase) to consistently capture customer complaints. o Developed Post Market surveillance plan by defining the processes required to continually trend and monitor customer feedback, and to maintain risk at an acceptable level in accordance with risk management files.
o Worked on complaints closures and supported CAPA tasks for marketed product. o Successfully led the effort of assessing the MDR reportable event for problem codes based on risk profile and regulation requirements. o Successfully participated as Quality representative on Change Control and Material Review Board.
o Responsible for documenting and maintaining necessary files per departmental policies and procedures (GMP and GCD).
o Conduct quarterly audit for product quality on product replacement referrals. Gurpreet Grewal
5042 Marshall Ct, Wadsworth, IL-60083
********@*****.***
2
o Responsible for implementing and maintaining the effectiveness of the quality system by assisting the pharmacist in the practice of pharmacy in accordance with federal, state, and local regulations, HIPAA and FDA guidelines.
o Responsible for coordinating study start-up activities, including study design, protocol, delivering initial welcome packets, updated contracts per study needs, and information regarding drug delivery and returns.
o Updated procedures and work instructions as required.
Certified Pharmacy Technician: Osco Pharmacy, Waukegan, IL (May’11 to Sep’12), Walgreens, Edina, MN (Aug’08 to Mar’11), Cub Foods Pharmacy, Shoreview, MN (Jan’08 to Sep’08), Osco Pharmacy, Waukegan, IL (Dec’01 to Jan’ 07)
o Assisted Pharmacy Manager with product recalls (reached out to customers in order to bring recalled product back, maintaining records, responsible for storing and sending recalled product back to supplier/vendor).
o Interacted with insurance companies to resolve customer’s insurance issues. o Worked with registered Pharmacists' and successfully completed all the tasks assigned. o Effectively communicated with Physicians' and Nurses to clarify new prescription orders and obtain refills.
o Diligently gathered customer background information, medical and prescription history. o Organized and coordinated patient records by compiling data, initiating new patient file, and updating existing files.
o Monitored and maintained pharmacy inventory.
o Responsible for maintaining and releasing medical records to the patients. o Maintained patient files and information in the pharmacy in accordance with federal, state, and local regulations, HIPAA guidelines.
o Actively participated in internal and external pharmacy audits. o Managed controlled products (CII) inventory and performed weekly and monthly audits. o Reorders as necessary to maintain a continuous inventory of medications and supplies.
Certified Pharmacy/Lab Technician at Northwestern Lake Forest Hospital, Lake Forest, IL (Mar’06 to Jan’07)
o Assisted Pharmacy Manager and Director with records maintenance, storage and returns of recalled products.
o Prepared intravenous admixtures and enteral feedings by calculating necessary quantities of each component and selecting correct components from stock shelves. o Managed filling and delivery of prescriptions to various departments. o Investigated and fixed miss count issues, patient charges/credits, managed inventory. o Carried out special projects such as drug protocol audits. o Processed patient charges and credits by validating and charging fill.
EDUCATION: Bachelors of Science in Healthcare Management from Southern Illinois University, Chicago, IL (in progress will be completed September 2021)
Certification and Skills: Certified Pharmacy Technician (PTCB), Working knowledge of 21 CFR Part 820 and 803, ISO 14971:2012, ISO 13485:2003 and ISO 9001:2015
Tools Used: TrackWise/KabiTrack for CCM (Change Control Management), Complaint Management, GCMW (Global Complaint Management Workflow), SAP
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