The Quality Control/Quality Assurance (QA/QC) Manager provides regulatory and quality guidance and approvals. Specifically, developing and performing appropriate testing on finished products produced by Ideal Cures and raw materials used by Ideal Cures in manufacturing. The role is based at Ideal Cures’ US location in Sterling, Virginia with potential for occasional travel to customers as needed.
Responsibilities & Duties:
Be responsible for all quality activities related to Ideal Cures manufacturing processes and products.
Lead operations personnel to ensure cGMP practices are adhered to.
Be conversant and responsible for all validation/documentation activities such as validation master plan, process validation, method validation, cleaning validation, equipment qualification and validation applicable to the site and the products.
Provide appropriate supporting documentation related to Ideal Cures’ products to customers.
Oversee quality control of raw materials used in production and certify vendors meet the quality standards required by Ideal Cures and its customers.
Collaborate with Ideal Cures technical support and commercial personnel on product development.
Understand the key features and benefits of Ideal Cures’ Technologies. Provide support for their potential application based on customers’ drug release, formulation and processing requirements.
Collaborate with New Product Development (NPD) group and QC personnel in India in technology transfer of new products.
Travel as needed to customer research and manufacturing sites to support the use of Ideal Cures’ products.
Prepare and present technical information (oral and written) for both internal and external use.
Develop and maintain implementation of appropriate quality practices as dictated by customer and various regulatory body guidance.
Use business software tools to maintain quality database, and capture notes of key customer interactions. Must also be proficient in Excel, Word, and PowerPoint.
BS. Degree in Pharmacy, Chemistry, Chemical Engineering, or related scientific discipline required. Advanced degree preferred
Minimum of three years of experience in a regulatory or QA/QC role in a pharmaceutical ingredient or pharmaceutical/nutraceutical finished goods manufacturing environment.
An understanding of the pharmaceutical production and registration process is preferred
Knowledge of cGMP and associated regulatory guidance in the manufacture of pharmaceutical products.
Excellent oral and written communication skills required.
Fluency in English is essential.
Candidates should be conversant and responsible for all validation / documentation activities like (Validation Master Plan, Process Validation, Method validation, cleaning validation, equipment qualification and validation) applicable to the site and the products.
Additional Salary Information: Annual performance bonus ~20% of salary
About Ideal Cures US, LLC
Ideal Cures is India's largest and one of the world’s leading manufacturer of ready-to-use coating systems and pharmaceutical excipients focused on drug delivery. As a result of recent growth, Ideal Cures now has a new US manufacturing site and product development lab to serve companies in the US, Canada and Latin America.
With over 20 years of experience, 14 granted patents and 12 pending patents, Ideal Cures provides tailor-made solutions and products uniquely shaped to meet pharmaceutical and nutraceutical customer requirements. Ideal Cures’ product portfolio includes INSTACOAT® ready-to-use film coating systems, ECOPOL® range of Pharma Acrylic Polymer’s, ECOCOOL® brand of cooling compounds, ESPHERES™ for drug layering technologies and INSTANUTE® coating technology for nutraceuticals and dietary supplements. Virtually all Ideal Cures products are supported by a US DMF.
Ideal Cures prides itself on product innovation as evidenced by our numerous awards and first to market products specifically designed to meet customer needs and market demands. We are large enough to provide the world class service expected while maintaining a hands-on relationship with the companies we serve. Ideal Cures global headquaerters is in Mumbai.