Senior Manager Validation Sagent Pharmaceuticals
Quality Assurance & Facility Compliance
VP Quality Assurance & Facility Compliance
Independently plans, performs and documents commissioning and validation activities (DQ, IQ, OQ, PQ) for equipment, facilities and utilities in a finished dosage, parenteral drug manufacturing environment. Based on engineering specifications, performs validation projects that includes authoring protocols, executing validation protocols and writing reports of validation results. Leads the validation activities for large capital projects. Tracks and communicates progress of work against milestones. Writes validation plans, protocols and summary reports using provided templates. Collects and reviews validation data and dispositions tests. Routes documents for approval. Provides input towards the development of validation SOP?s and templates. Initial primary focus is Sagent?s initiatives in China including technical transfer.
- BS or MS degree in chemical, bio or mechanical engineering or related science.
- 7+ years of post graduate industry experience in finished dosage parenteral pharmaceutical equipment/facilities/utilities validation or quality engineering/assurance is also required.
- Knowledge of current industry standards and regulatory trends as they pertain to equipment/facilities/ utilities validation is necessary.
- The ability to independently troubleshoot and resolve issues that arise during validation execution is desirable.
- Candidate should have execution experience relative to process equipment validation, parts washer/autoclave validation, clean utilities validation and clean-in-place/steam-in-place validation.
- Ability to travel overseas (International travel 20 to 25%).
- Leads projects by developing validation master plans, schedules, resource loading, and other project deliverables as required. Based on engineering specifications, validates large capital and technically complex projects on equipment or processes that includes authoring protocols, executing validation protocols, and writing reports of validation results. Initial primary focus is Sagent?s initiatives in China.
- Represent the validation engineering department to provide validation master planning on primarily large capital projects. Provide technical leadership on cross-functional investigation teams. Assists in writing regulatory filings and represents validation in regulatory audits/inspections.
- Serve as key Technical Transfer contact providing on-site support.
- Leads a cross-functional team in developing validation best practices, standards, and guidelines, which includes exploring new techniques, methods, and other industry practices.
- Review and approve Validation protocols and summary reports generated by validation staff against standard procedures and policies. Provide guidance to validation staff writing protocols and final reports.
- Develops training material and implements a training program to ensure consistency among Sagent?s partners and contract manufacturing organizations including in particular Sagent?s initiatives in China. Ensures completeness, accuracy and compliance of all supporting documentation.
- Provides Quality Assurance and Facility Compliance guidance and support in all aspects of cGMP including in particular aseptic processing, basic microbiology, environmental monitoring, thermal validation, proper gowning techniques, evaluating media fills, microbiological identification, lyophilization, SIP and CIP systems, good documentation practices and root cause analysis during investigations.
- Assists senior quality team in performing mock FDA inspections of Sagent vendors? and distributor?s operations to ensure vendors? and distributor?s cGMP systems can withstand FDA scrutiny, as relates to validation.
- Interacts with regulatory officials to convey to compliance level of various quality systems during regulatory inspections.
- Independently and proactively seeks new information to assure current status with compliance and regulatory issues through evaluation of available documentation, e.g. other company?s warning letters and 483?s, cGMP Trends, new FDA Guidance documents, PDA, etc. Share?s obtained information with other applicable Sagent departments.
- Acts on VP of Quality Assurance & Facility Compliance?s behalf, as designated.
Specific Technical/Job-Related Skills:
- In depth knowledge of current FDA GMP regulations as well as FDA trends and guidelines with a core specialization qualification and validation.
- Ability to speak and read English
- Experience in validation of aseptic operations.
- Candidate must be results-oriented, able to make decisions and able to prioritize work per business needs. Strong communication, organization and time management skills are necessary.
- Teamwork, leadership and the ability to maintain constructive relationships with personnel from various disciplines at all levels in the organization are desired competencies.
- The successful candidate should demonstrate integrity, reliability, dedication, adaptability, innovation and self-motivation.
- Proficient with PC-based word processors, databases and spreadsheets.
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Schaumburg, IL 60195