Shire traces its history back to 1986, when a small team of entrepreneurs sought out a solution to address on a number of unmet medical needs. Within its first two years of operation, the company had launched a range of supplemental calcium products for patients seeking to treat or prevent osteoporosis. Soon thereafter, innovative drug development programs were under way on behalf of patients facing such challenging conditions as Alzheimer's disease and end-stage renal failure.
Post : Quality Assurance Specialist
Primary Role
- Perform quality operations for Shire in India to ensure its compliance with local regulatory authority and Shire’s global requirements for importation, local testing, repackaging, storage and distribution of Shire products.
- To perform sample submission, related documentation creation, review, end to end process execution, tracking of testing of products from Indian Govt. Laboratories.
- Perform/support activities for Shire in India to develop, implement and maintain a systematic, effective and efficient local Quality Management System (QMS) as per local regulatory authority and Shire’s global requirements.
- Perform/support quality activities and resolve quality issues for Shire in India to support the continuous supply of Shire products in India in compliance to local regulatory authority and Shire’s global requirements.
- Provide relevant quality support to all relevant post market activities for Shire in India so that these activities are executed timely as per local regulatory authority and Shire’s global requirements in order to minimize any product supply interruption.
- Perform/support activities contributing to the management of the relationship, relevant communication and inspection with local regulatory authority on Controlled Substances matters for Shire in India
- Provide quality support timely to local business projects and product launches in India.
- Provide support to other APAC countries’ quality operations if needed.
- Maintain all quality related documentation.
Essential Duties & Responsibilities
- Perform/support local quality activities related to the importation, repackaging, release, storage and distribution of Shire products in India timely and according to the local regulatory authority and Shire’s global requirements so as to support the continuous provision of quality complaint Shire products in India
- These activities include but are not limited to: Local product testing, product release (shipment temperature & repackaging document review), personnel training, document creation/maintenance, 3PL warehouse management, product complaint handling, field correction action, supplier/distributor management and internal/external audits.
- Resolve all relevant local product quality issues timely to ensure continuous provision of quality compliant Shire product in India.
- Provide relevant quality support to all relevant post market activities for Shire in India so that these activities are executed timely as per local regulatory authority and Shire’s global requirements in order to minimize any product supply interruption.
- Perform/support activities for Shire in India to develop, implement and maintain a systematic, effective and efficient local Quality Management System (QMS) as per local regulatory authority and Shire’s global requirements.
- The QMS includes but are not limited to: documentation control, personnel training management, product release, product sample management, product complaint handling, field corrective action, recall, change control, deviation/CAPA, supplier management, internal/external audit and management review,
- Perform relevant quality activities to support that maintenance of any local company certification (e.g. Good Storage Practice).
- Manage relationship, relevant communication and inspection with local regulatory authority on GWP, GDP and Controlled Substances matters for Shire in India.
- Perform/support activities contributing to the management of the relationship, relevant communication and inspection with local regulatory authority on Controlled Substances matters for Shire in India
- Provide support to ensure all KPIs for local quality operation for Shire India meet the established requirements.
- Provide Quality support timely to local business projects and product launches activities in India.
- Provide support to other APAC countries’ quality operations if needed.
- As an active member of Shire Global QA Community, contribute to develop and strengthen Shire global quality management systems, and provide flexible support to Shire business both at the country and country cluster level and global level.
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Education & Experience Requirements
- Successful completion of relevant tertiary qualification – science degree / Pharmacy.
- 3-5 years’ experience in Pharmaceutical Company in quality function with minimum 1-3 years in GMP manufacturing plant environment and/or, 1-3 years in commercial Quality office environment.
- Good knowledge and experience in working on the development, implementation and maintenance of a Quality Management System compliant to local India regulatory requirements on NMC corporate standards and/or Good Storage Practice (GSP) or Good Distribution Practice (GDP).
- Good knowledge and experience on managing/performing quality operation activities and the regulatory requirements for the importation, repackaging, release, storage and distribution of pharmaceutical products (including solid dose, biologics and cold chain).
- Sound knowledge and experience in working with cGMP and/or quality management system elements and guidelines (e.g. PIC/s, ICH, ISO9001 or ISO 13485) and cold chain product repackaging.
- Experience in handling electronic systems for QMS (Change controls, deviations, CAPA, complaints, audits, training) and batch release (ERP system).
- Experience in managing supplier audits, internal audits, regulatory authority inspections.
- Ability to work independently and identify compliance risks and escalate when necessary
- Good sense of urgency and strong follow up
- Scientific Knowledge
- Ability to manage complex projects and timelines in a matrix team environment
- Demonstrated interpersonal skills including strong negotiation skills
- Excellent teamwork and coordination skills
Additional Information:
Experience : 3-5 years
Qualification : Science degree / Pharmacy
Job type : Quality Assurance
Location : India-Haryana-Gurgaon
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