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: Director - Biologics Compliance
Job Description
This position leads an area that provides critical cGMP compliance support, data verification, staff training, assurance of scientific document control, data integrity evaluations/consulting, conducting needs assessments and delivery of various compliance initiatives to address needs, managing the CAPA effort within Hospira India R&D, and evaluating effectiveness of initiatives and corrective actions. This position assures that Hospira India Pharmaceutical R&D remains in compliance with Hospira corporate polices and procedures and applicable federal regulations. Assesses effectiveness of the Hospira quality system through the conduct of compliance assessments. Provides consultation and assistance to Pharmaceutical R&D personnel on compliance issues. Participates as lead contact during R&D inspections by external areas, including Hospira Quality, Regulatory agencies, and One2One® customers. Participates on cross functional teams to help resolve issues. Identifies, develops, and implements cGMP continuous improvement initiatives. Maintains industry and regulatory knowledge of new and evolving compliance requirements and trends, and communicates these requirements and trends to R&D personnel by developing plans to assure compliance. Recognizes compliance issues and leads cross functional teams to help resolve issues. Represents Hospira India R&D on corporate compliance initiatives. Performs the compliance functions necessary to support R&D’s Drug Development Groups, (Generics, One-to-One, ESD and Plant Support). This includes oversight for preparing and implementing documentation with all phases of the development process and reviewing and approving all validation and exhibit batch activities focusing on ensuring the acceptance of data and reports by various regulatory agencies throughout the world.
MAJOR DUTIES AND RESPONSIBILITIES:
- Oversees the compliance review and approval on all test method validation documents generated by the Generic, One2One, ESD and Plant Support Groups in Hospira R & D.
- Responsible for supervising individuals who perform the final laboratory review of all data (chemistry, microbiology, pharmacology and particulate matter) generated within the Hospira India Pharma R & D Group.
- Responsible for oversight in preparation and compliance review of monographs, batch records, First Lot to Stock (FLTS) documentation and approvals on all Certificates of Analysis for use in FDA Submissions. Assures that all testing procedures/ monograph and SOP’s are compliant with the USP, BP, EP, JP and ICH supplemental updates, and are compliant with the FDA submission documents and FDA correspondence letters.
- Responsible for planning, execution, and follow-up of monthly laboratory compliance assessments for the Hospira India Pharma R & D laboratory.
- Responsible for the oversight of the preparation and maintenance of comprehensive Pharma R & D training program.
Skills/Experience Education/Certification
Education:
To be able to interpret, explain, and apply current FDA regulations and requirements, perform an effective assessment of the Hospira quality system and make good scientific judgements during evaluation of test method validations and investigations, a Bachelor’s Degree in physical science, life science, nursing, pharmacy or equivalent experience is required.
Experience:
A minimum of seven (7) years experience in the pharmaceutical industry with increasingly challenging responsibilities in scientific and compliance areas is required. Knowledge gained through this experience must include a thorough understanding of analytical method validations, GLP’s and cGMP’s, and regulatory/compendial requirements for the development of pharmaceutical products.
Problem Solving:
The incumbent in this position must be able to use his or her working knowledge of Compendial (USP,EP,etc.) and ICH Guidance Documents, FDA Guidance Documents and Hospira Guidance Documents to ensure the appropriate quality standards are maintained while meeting aggressive deadlines. The position holder must also exhibit excellent communication skills to effectively communicate standards and expectations to dozens of R & D Scientists. The position holder must be able to manage and prioritize multiple projects with multiple competing deadlines. Incumbent needs to have a thorough understanding of the depth and breadth of drug development so they can contribute to discussions to resolve issues.
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Accountability:
Thorough review of the content of validation protocols and reports and other submission-related documents is critical to the success of regulatory submissions and Hospira’s business success. The incumbent must be a qualified Subject Matter Expert (SME). As the Subject Matter Expert, the position holder is ultimately responsible with the R&D project leader, manager, and Corporate Quality for the overall content of the R & D documents and reports. Accountable for understanding and complying with the applicable regulatory guidelines. All documentation generated within R & D would be reviewed by the incumbent prior to releasing documents outside the department. In many cases this is the final review before the document(s) are published.
Analytical Ability:
Analytical ability is a must for this position. The person in this position must be able to understand and interpret the complex chemical and biological analytical data to ensure that appropriate validation parameters are selected, and that the criteria set for those parameters are appropriate and have been met. This includes hands-on review of the raw analytical data and associated documentation. This position is responsible for the Quality and/or SME final review for all protocols and validations along with the QA. For many other documents this position is the final review prior to issuance of the document.
Authority to Act:
This position holder serves as the senior Compliance approval for the R & D work described previously and receives very limited supervisory review. Coaches and trains the junior scientists within R&D on report style and format. Has responsibility for informing the appropriate Department Manager of suspect data and for subsequent investigation. As a SME, the person in this position must be in agreement with the validation requirements or be able to take a solid scientific stance if there is a difference.
Additional Information:
Auto req ID: 17733BR
Qualification: B.Pharm, B.Sc, Graduation
Location: Chennai, Tamil Nadu
Functional Area: R&D
Employment Type: Full Time
Job Type: Regular
End Date: 30th September, 2015
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