Raisa Siddique Email & Phone Number

Amelia, Oh, Us

Amelia, Oh, Us

Sharonville, Ohio, United States

Working with fellow quality assurance team members to promote FDA compliance in terms of document review for GDP/compliance issues, assistance with audit readiness, and deviations management.• Retrieval of documents in order to prepare for/assist with company audits (create scans, copies of SOPs and/or other documents)• Creation and maintenance of deviation, OOS, and CAPA logs. Weekly enter relevant information onto Shared Drive of deviation spreadsheet for ease of access as well as following up on deviation closure• Liaison between consulting firms and the company. Organization of files sent and received/approved to maintain timely closure and ease of access• Writing of deviation reports to offer insight on state of procedures, and if modifications are needed to existing processes/procedures• Collaborated with other departments (i.e., QC, Regulatory Affairs) to achieve company overhaul of validations in creation of an organizational system.• Streamlining of data gathering by utilizing OneDrive, a relatively new technology to the company, saving time and energy when multiple associates can make changes to the same viewed window • Responsible for safekeeping/effecting SOPs to ensure procedures are up to date with training of personnel• Completion of receiving reports (RRs) filing them in which they can be easily retrieved to reference raw materials used

Wilmington, Ohio, United States

Collaboration with QA operations team to achieve regulatory compliance driven by FDA guidelines in the form of record review, observation of production activities, performance of finished material AQL visual inspections, inspection of rooms/equipment, and walkthroughs of production floors and warehouse/utility facilities. • Detail oriented review of production batch records with respect to manufacturing and have corrections made on a timely manner. Perform monthly SAP transactions in accordance with SOPs to maintain correct inventory. • Collaboration with multiple departments (i.e. Validation, Quality Control) in order to follow a record to completion• Perform tasks in accordance to SOPs with respect to navigating the QMS for audit readiness• Work alongside manufacturing to uphold cGMP and GDP standards, correct issues when needed • Assure quality of raw material (record review, monitoring production, etc.) tailored to SOPs of each finished product material (e.g., Risperdal Consta™, Vivitrol™, Aristada/Aristada Initio™, and Lybalvi™)• Close observation of manufacturing practices of novel antischizophrenic/bipolar disorder oral solid dose (OSD) therapy, Lybalvi™ to maintain regulatory compliance and validation protocols/procedures

Fairfield, Ohio, United States

Perform tests, record, and analyze data with precision and accuracy in accordance with policies and procedures while communicating with production for quality assurance. Maintenance of instrument/machine calibration and upkeep of lab while following strict lab safety policy, maintaining integrity of the sample.• Responsible for testing of products intended for manufacturing and research in fast paced lab. Contributed towards nearly $3.4 million in sales for the month of March 2021• Officially issue products for production with strong attention to detail in adherence to SOPs.• Use of analytical software (ex. Chemstation™, ADL Shell, EasyID™, etc.), and procedures such as spectroscopy and titration to ensure high quality

Centerville, Ohio, United States

Dispensed medications and coordinated verification hundreds of prescriptions in high-volume retail pharmacy. Offered exceptional customer service in answering queries and resolved concerns from customers, physicians, and insurance companies. Performed a wide range of pharmacy operations with strong commitment to accuracy, efficiency/service quality.• Rapidly trained in utilizing EasyFillPRN software used to track and monitor medication stock inventory, maintaining a low overhead.• Advanced customer retention strategies.• Promoted compliance of SOPs, resulting improved efficiency in filling prescriptions and higher prescriptions filled.

Master Of Science - Ms, Pharmacology And Toxicology

Activities and Societies: Rainbow Alliance, Bangladesh Student Association

Bachelor Of Science (B.S.), Biology/Biological Sciences, General

Activities and Societies: Asian Student Association, Bangladesh Student Association, The Rainbow AllianceDean's List May 2014. Took part.