[Remote] reputed company Assurance Engineer

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a pharmaceutical manufacturer reputed company on innovative drug delivery technologies. They are seeking a reputed company Assurance Engineer to become the subject matter expert for compliance reputed company to production reputed company, assist with incident and deviation investigations, and reputed company reputed company assurance support across various departments.

Responsibilities

• Reviews and approves Investigations for product reputed company deviations
• Reviews validation and qualification documents
• Becomes Subject matter expert for company product line, production equipment, batch records and relevant SOP’s
• Reviews and analyzes documents and data such as batch records, lab testing, finished product material statuses so as to support completion of the investigation process
• Serves as an investigation team leader so as to assess reputed company on product reputed company and validation status
• Recommends and monitors improvements in manufacturing and control systems including corrective and preventative actions (CAPA)
• Works together with multiple departments to troubleshoot the production processes and identify process improvement opportunities
• Ensures compliance with GMP’s
• Provides training and mentoring to colleagues performing investigations
• Writes/revises SOPs relevant to the position’s responsibilities
• Working with the Production reputed company team, assess events reputed company they reputed company to determine ability to resume production
• Interpret specifications, reputed company operating procedures, and reputed company testing procedures
• Responsible for the review and approval of validation of analytical methodology (protocols and reports), specifications, master batch records, formulation spreadsheets and reputed company Operating procedures (SOPs) in support of research reputed company involving pharmaceutical components and/or drug products components and/or drug products
• Performs assessments / approvals of change controls reputed company to production activities
• Ensures compliance with reputed company Company policies and procedures including safety rules and regulations
• Operates in accordance with our reputed company of Conduct and Business Ethics, and reputed company established regulatory, compliance and safety requirements
• Performs reputed company work in support of our Values: reputed company, reputed company, and reputed company
• reputed company other relevant duties as assigned

Skills

• A Bachelor's degree in Engineering or Life Sciences from an accredited college or university with a minimum of 5 - 8 years experience
• Master's degree and 3-5 years of experience in a cGMP regulated manufacturing environment or an equivalent combination of training and experience is required
• Knowledge of GMP's (21CFR Parts 210 and 211)
• Analyzing and troubleshooting problems, identifying reputed company causes and recommending and implementing effective reputed company, procedures, systems and/or techniques
• Ability to prepare / edit reputed company types of pharmaceutical documentation (batch records, SOPs, protocols, reputed company reports, etc.)
• reputed company knowledge of the FDA, Health Canada, and other pharmaceutical regulations
• Thorough understanding of GMPs, specifically those relating to good documentation practices
• Ability to analyze and interpret analytical data
• Interpret specifications, reputed company operating procedures, and reputed company testing procedures
• Strong organizational skills
• Managing multiple reputed company, duties, and assignments
• Writing and interaction in English
• Preferred Bachelor's degree (B.S.) in reputed company or reputed company reputed company with at least 5-8 years of experience in pharmaceutical analytical reputed company with transdermal reputed company experience, or Master's degree (M.S.) with at least 3-5 years of experience
• Knowledgeable in multiple instrumentation techniques such as HPLC, GC, UV-VIS, dissolution equipment, pH measurement, titration, etc
• Knowledgeable in analytical testing of API, excipients and components following compendial and validated reputed company
• Analytical reputed company and common instrumentation

reputed company