Padmarani G. Email & Phone Number

Boulder, Colorado, United States

United States

• Author, Review, Update and contribute to continuous improvement of departmental SOP’s.• Interacted effectively with Quality Control, Manufacturing, and R&D Departments regarding documentation requirements for FDA submissions, CDPHE and Organic certifications, ensuring departmental timelines are met and kept up to date.• Participates in project development teams and reviews plans, reports, risk management and design reviews associated with product and process projects intended for inclusion in regulatory submissions.• Validated Vendor Qualifications• Released raw materials and final products by creating and verifying COAs.• Managed testing program for all products and raw materials.• Applied Pharmaceutical Manufacturing knowledge in R&D gummy production to create successful new formulas.• Interact with customers for their requirements, reverse Engineering process and deal with product development update.• Perform Internal Audits and Environmental Monitoring.• Approve Change control, CAPA and planned deviations.• Investigation of OOS, OOT and extraneous peak as per SOP, plan brainstorming sessions and perform hypothesis accordingly.• Works collaboratively in a team environment to improve processes, while maintaining awareness of ensuring high-quality assurance.• Ensure Document control, Author and Review Pre and Postproduction Batch Records.• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.

Boulder, Colorado

Reviewed batch records on the production floorReviewed and updated SOP's and LogsReviewed and approved production startup activities including but not limited to, cleaning of production areas, equipment set up, labels, batch records and cartons issued etc.Performs monthly Internal AuditsSample and release raw materials including bulk hemp samplingMonitored pest control program to ensure complianceAssist other projects given by manager.>Ensure compliance of the company’s quality programs with federal, state, and local regulations, as well as customer specifications and company standards >Reviewed pre and post production Batch Records as per SDP>Maintained current HACCP/ Food Safety and Food Quality Plans for all applicable products and processes>Maintained Label inventory and make sure latest version of label usage >Maintained Environmental Monitoring Program and conducted trending of results>Investigated all consumer complaints and other quality issues, determined root cause and corrective/ preventative actions, and followed up to ensure that resolution had occurred >Maintained most current product specifications and make sure latest version is active in all departments >Developed, maintained, and trained on all documents related to Quality Management System and the SQF auditing system, including all SOPs and company GMPs >Maintained company’s compliance with the requirements for SQF, Organic, and Kosher certification; participate in third party and customer audits and inspections, and ensure completion and submission of all corrective actions >Developed best methods and drive continuous improvement and efficiencies for QA >Ensured effective safety procedures, tools, and record keeping are managed through site leadership

Colorado, Usa

• Meet established productivity and quality standards for AT1• Know and follow all safety requirements• Work accurately and effectively from operating procedures and drawings• Strictly follow MOP and SOP• Handle, collect, label and transfer hazardous chemical waste following established procedure and guidelines• Ensure equipment is calibrated and in acceptable working condition prior to use• Accurately document production related activities• Identify and report deviations from accepted practices and quality concerns.

Madurai , India

• Complete understanding of GMP standards• • Performed qualitative and quantitative analysis of raw material, finished product, stability, process validation and cleaning validation sample-using analytical instrumentation such as GC, UPLC, HPLC, TLC, UV/VIS Spectroscopy, pH metry analysis, particle size analysis, Karl Fischer, wet chemistry, etc.• Followed the cGMP regulations and performed Quality Control (QC) testing on tablets.• Executed analytical methods of pharmaceutical solid dosage forms especially for assay, content/ blend uniformity, dissolution and identification.• Worked in a team environment to undertake physical tests on tablets and capsules.• Exercised particle size distribution, bulk and tap density with powder flow property for experimental and final batches.• Material handling, inventory upgradation and safety precaution were carried out during the tablet press operation.

India

• Managed drug inventory, ordering medications and supplies for replenishment, verifying deliveries against purchase orders, and resolving any discrepancies • Dispensed medications according to written prescriptions with 100% accuracy with more efficiencySelling over-the-counter medicines.Counseling and advising the public on the treatment of minor ailments.Advising patients of any adverse side-effects of medicines or potential interactions with other medicines/treatments.• Knowledge of principles of pathophysiology and drug action • Oriented and trained new staff on proper procedures and policies• Collected, organized and restocked supplies in all units.• Attended required training, education and meetings• Pharmaceutical storage awareness• Computer savvy with interest in learning new technologies• Interpersonal, organizational skills and analytical thinking

Bachelors In Pharmacy, - Pharmacy, Pharmaceutical Sciences, Pharmacology, Pharmacognosy, A

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