Quality Specialist - Development & Validation

at  UNITHER PHARMACEUTICALS

WHO WE ARE?

We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible.
With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.
Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 280 employees.
The Quality Specialist (Development and Validation) assists and supports the organization with initial compliance, testing and ongoing monitoring of established quality assurance processes. Ensures all standards are upheld for the development of new pharmaceutical products, validation of developed processes and the manufacturing and production of commercial drugs. The Quality Specialist effectively conducts and supports problem investigations for validation and product development issues. The Specialist will review and approve a wide variety of GMP related documents and will serve as an internal organizational contact and may represent the department on various teams. Externally, the Specialist will work directly with customer quality assurance and technical teams.
Effective & Efficient Processes (50%)
Acts as the primary Quality Assurance representative working with Customer teams, Internal Project Managers and representatives for all product development and commercialization related activities.
Establish and maintain partnerships with internal teams and external organizations supporting development, technology transfer, process validation, and commercialization of drug products.
Resolves problems, identifies trends and develops program improvements related to development and technology transfer across multiple programs and sites.
Ensures compliance with internal procedures and regulatory expectations by proactively working internally and/or with customer Quality organizations.
Understands manufacturing and packaging equipment functionality; works with project teams during equipment/facility qualification to ensure compliance in accordance with company SOPs and industry standards.
Provides Quality oversight to the drug development process, including safety, toxicity and regulatory compliance and the review and approval of documents such as process and cleaning development protocols and reports, batch cards, raw material test methods and specifications, finished product test methods and specifications etc.
Provides Quality oversight to the validation maintenance of the site, including review and approval of documents such as Validation Master Plans, process validation protocols and reports, cleaning validation protocols and reports, cleaning recertifications, equipment and chamber qualifications and recertifications, utility validations and recertifications, sterilization validation and recertification, media fill tests, etc.
Liaison with internal and external teams to support the commercialization of successfully validated drug manufacturing processes in accordance with cGMPs.
Conducts risk assessments of current processes against regulations and industry standards.
Informs management immediately of any quality related concerns and risk to the organization.
Monitors document management process, ensuring that related documents and records are in accordance with Unither policies and federal and international regulatory guidelines.
Independently conducts development quality investigations and tracks progress of related corrective action plans.
Assists with internal and external audit schedules.
Drives the change management system for the development and validation of processes.
Customer Related Documentation (25%)
Reviews and approves customer-based change controls and communicates changes and process modifications in a professional and timely manner.
Reviews and approves Certificates of Analysis (COA) and Certificates of Compliance (COC) for development products based on finished product specification requirements.
Reviews and approves customer related documentation for batch records and operational specifications and providing to the customer in a timely manner.
Supports quality investigations for product development projects with documentation provided to customers.
Assist with customer filing documentation.
Batches of Material Dispositioned (10%)
Reviews and approves development and process validation documentation to ensure that packaging components, raw materials, supply items, intermediates, and finished product is manufactured, sampled, packaged, tested, held, and released in a manner consistent with cGMP requirements.
Monitors data in several systems to ensure there are no product quality concerns.
Supports activities related to the review and release of packaging components, supply items, raw materials, customer/contract materials, intermediates, bulk and finished product received/used/shipped from the Rochester Site, including damaged material, expired material, inventory management and deviations.
Supports transactions to place or remove a Quality (and/or Validation) Hold within the ERP system to block or release raw, WIP or finished inventory from shipment or progression as the result of notification from the production floor.
Support and Guidance for site departments (15%)
Provides QA support for non-commercial production activities such as media fill tests.
May be required to provide GMP training to new hires.
Facilitates cross functional building of change controls.
Drives and ensures completion of cross functional deviation investigations.
QA/compliance experience in manufacturing, facility operation, laboratory compliance and quality systems preferred.
Must be able to recognize situations where there is a potential impact on product quality, safety, identity and purity.
Meticulous, attention to detail
Knowledge or understanding of sterile and non-sterile practices.
An analytical and systematic problem-solving approach
Excellent communication and collaboration skills
Data analysis and reporting experience a plus!
B.A./B.S. Chemistry, Biology, Pharmacy, Health Science or Related Field required and 2 years of experience; Masters degree preferred.
Experience working in a federally regulated environment, specifically cGMP regulations experience. Preference for Pharmaceutical industry

Please refer the Job description for details