Hospira is the world's leading provider of injectable drugs and infusion technologies. Through our broad, integrated portfolio, we are uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs.
Through our offering of high-quality, lower-cost generic medications, we continue to help reduce the overall costs of healthcare — to improve both the affordability of care for patients and the financial strength of the global healthcare system.
Post: Senior Manager-MS&T Compliances
Job Description
· Identify gaps and improvement areas to ensure compliance for all the MS&T activities to support Aura operations such as:
- Qualification of new vendor for key starting materials, critical materials, recovered solvents, etc.
- Conducting experiments to improve quality and manufacturing process efficiency
- Supporting commercial batch investigations (OOS)
· Develop comprehensive remediation plan to ensure compliance with cGMP and GLP expectations / Pfizer corporate quality standards with specific emphasis on:
- Compliance of laboratory equipment and instruments to 21 CFR part 11
- Validation and calibration requirements
- Documentation and GDP
- Laboratory controls and infrastructure to support experiments / analysis
· Execute remediation plan /activities based on the risk, and coordinate with other functions to ensure resolution of issues and completion of activities in time
· Develop risk mitigation plans on newly identified event and / or additional risks identified during program execution
· Coordinate with R&D to ensure that procedures, policies and best practices applicable to MS&T across other Pfizer sites are integrated with Aura MS&T operations
· Provide periodic updates to Remediation Head on the progress of MS&T remediation plan
Capability Development / Training of MS&T
· Coach and advise the MS&T team to facilitate identification of root cause of laboratory failures and development of CAPA, and adequate closure of investigations
· Improve technical writing skills of MS&T staff to provide absolute clarity on the objective, conclusion and recommendation of the experiment or study conducted to support plant operations
· Provide training to MS&T and production team on newly created procedures, and improve their skills to identify root cause of product failures and development of investigation plan
Develop skills and train the MS&T team for FDA inspection readiness – e.g. upkeep of lab, document management, auditee skills, writing storyboards on key activities, answering questions on investigations and OOS, etc.
Skills/Experience Education/Certification:
* Masters in Pharmacy or Science, with Specialization in synthetic or analytical chemistry
* 8 + years of experience in API manufacturing or technical operations, with at least 3 years in manufacturing of Sterile products
Additional Information:
Auto req ID: 21095BR
Qualification: Masters in Pharmacy or Science
Location: Aurangabad, Maharashtra
Functional Area: Quality Assurance
Employment Type: Full Time
Job Type: Salaried
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