Download App | FOLLOW US ON SOCIAL MEDIA
 Upload Your Resume   Employers / Post Jobs 

Corporate Attorney in Broomfield, CO

Sandoz Oct 07,2014 Sep 11,2014 Location USA Broomfield CO
This job is expired...

In-House

Attorney

Corporate

Litigation - Whistleblower - CFTC

Min 4 yrs required

Profile

Manufacturing Science & Technology_ Product Steward Duties: Owns the process knowledge of the products assigned throughout the commercial lifecycle, maintains the oversight on process capability, through data trending and statistical analysis of critical parameters, ensuring processes are robust, in continued state of validation and continuously improving. Owns the weak point product remediation activities. Ensures seamless flow of knowledge and information across functions, and with other sites when applicable, with focus on the products. Maintain the oversight of the process of the products assigned ‘door to door’ at the Site (e.g. from raw materials to primary packaging). Maintain the knowledge and the history of the products process throughout the entire commercial lifecycle, since transfer from development to date. Single Point of Contact to Global Product Steward: Oversee all process and packaging validation activities and weak point product remediation projects. Create and maintain a product specific Quality Risk Analysis (QRAs). Continued Process Verification (CPV), data trending and statistical analysis: Track CPV parameters from production, QC, control systems, etc. Monitor all critical variables and key variables as appropriate for the assigned product(s) (Critical Process Parameters CPP, In Process Control IPC parameters, Quality Attributes, Characteristics of raw materials. etc) using statistical analysis and conducting regular product specific data trending. Utilize data trending and statistical analysis to: Deepen and broaden process understanding and knowledge. Detect issues in process capability, such as systematic quality defects. Identify trends of process deviations (e.g. deviation with common root cause). Issue quarterly/annual data trending report. Assist initiating the product-specific monitoring of all critical In Process Controls (IPC) and release parameters in each laboratory (transfer of the product-specific Quality Risk Analysis). Ensure data and trending is visible and communicated at shopfloor level. Technology Transfer process: Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site. Provide the necessary support for the technical activities involved in transferring in a commercial product, focusing on critical process parameters, critical material attributes and critical quality attributes, supporting subsequent process and packaging validation activities at the receiving site. Investigations/improvement on product: Initiate and support investigations and improvement projects (quality, efficiency), based on the above data analysis, involving cross-functional teams. Actively participate and represent their product(s) in the relevant committee (e.g. Product Stewardship Committee), where the improvements on weak point products are planned, prioritized and monitored. Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters. Validation: Provide all necessary information to perform the validation process together with the validation Lead or validation experts. Plan revalidations/verifications/CPV together with the validation lead, consulting approving and reviewing the process validation master plan, together with the validation lead or validation experts. Testing Monograph oversight: Ensure oversight on Testing Monograph, liaising with Analytical Services to ensure consistency of content. Change control: Participate and/or lead (case by case) the change controls to its products and related processes. Ensure alignment of (regulatory) timelines for technical changes (e.g. DS), transfers or launch, major deviations. Annual Product Review/Product Quality Review (APR/PQR): Review the APR/PQR data and provide the correct level of discussion on it. Training: Own the Training Curriculum for its Job Profile and provides the necessary training and support to new associates joining this position. Audit support: Maintain their work in inspection readiness level and to provide the necessary support in any internal or external audit. Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.).

Qualification and Experience

Requirements: BS required. MS, PhD, JD a plus. Fluent in written and spoken English. 4 years of experience in regulated operations, quality, or development. Prefer pharmaceuticals, solid oral dosage. Must be able to organize and prioritize work. Project management skills preferred. Must have commercial product technical support experience/knowledge.

Additional info

Job ID: 150773BR

Company info