Sr Quality Specialist, Commercial Quality

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Job Description

OBJECTIVES/PURPOSE

• LOC Senior Quality Specialist oversees all GxP quality operations aspects to ensure compliance with local regulatory requirements and Takeda’s Quality Management Systems.
• Responsibilities cover the execution of GxP regulated activities including in-country distribution quality.
• Works in collaboration with local cross-functional stakeholders with focus on patient’s needs, regulatory compliance and continuous improvement.

ACCOUNTABILITIES

• Execution of quality operations to ensure its compliance with local regulatory authority and Takeda’s global requirements for importation, local testing, product release, repackaging, storage and distribution of Takeda products.
• Local batch release activities including temperature records evaluation, ERP system release, documentation verification & review, coordinating with suppliers & origin sites for records availability, disposition of imported stock for local batch release
• Maintaining all local procedures & processes of commercial Quality for redressing and local batch release and training of procedures to relevant stakeholders including suppliers
• Performing product impact assessments & coordinating with global team & suppliers (if required) for stability assessments (as required) for commercial Quality products in India
• As Quality Business Partner with local stakeholders, ensure quality support to local business projects and product launches are successful delivered in adherence to quality and regulatory compliance.
• Maintain redressing activity at LOC including process facilitation with supplier and disposition of redressed product by Takeda team. This includes (but not limited to) review & approval of redressing documents, redressing material approval request, additional supplier records as per supplier QMS, Takeda QMS records like deviation, change control, CAPA related to redressing, temperature records, disposition of redressed products.
• Maintenance of LOC QMS system and ensuring its KPI’s are met. This includes handling of applicable QMS elements (including but not limited to) Change control, deviations, CAPA, complaints, Risk mitigation, gap assessments etc for GxP activities.
• Maintain training management for local Quality procedures in Takeda LMS and assignment of it to identified target GxP audience (under the role of system training administrator)
• Providing support during self-inspection, Takeda internal audits, supplier audit, any Regulatory inspection for LOC
• Providing Quality oversight to supplier’s involved in GDP & GSP operations as per Quality agreement.
• Delegated quality operations to ensure compliance to Clinical Quality Assurance for local clinical operations (as back-up). 

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Good knowledge and experience as Quality Management Representative on the development, implementation and maintenance of a Quality Management System compliant to India regulatory requirements on Good Storage Practice (GSP) and Good Distribution Practice (GDP) and NMC corporate standards.
• Strong in managing/performing quality operation activities and the regulatory requirements for the importation, repackaging, product release, storage and distribution of pharmaceutical products (including solid dose, biologics and cold chain).

• Strong understanding with cGMP and quality management system elements and guidelines (e.g. PIC/s, ICH, ISO9001 or ISO 13485) and cold chain product repackaging.

Leadership

• Ability to collaborate and partner well with cross-function stakeholders locally
• Organization agility (knowledgeable about how an organization works) and ability to lead change, deliver strong results and build the confidence of stakeholders
• Ability to manage multiple and complex priorities, and to recognize when a change of priority is needed
• Execute goals and objectives in a driven and a high-performance culture with ability to achieve results

Decision-making and Autonomy

• Anticipate potential problems and risks related to quality systems/regulatory expectation, assess potential impact, implement compliant solutions to issues.

Interaction

Internal

• Key interactions with local key stakeholder groups to stay connected with business and respond to business needs.

External

• Key interactions with external GxP suppliers / distributor partners (as identified) to maintain good quality support.

Innovation

• Understanding of local industry, scientific and regulatory trends, and its market conditions and requirements.

Complexity

• Multiple external suppliers, supply & distribution models, regulatory frameworks and medical device requirements, and a wide diversity of products.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Minimum 5 years’ experience in Pharmaceutical Company in quality function
• Ability to work independently and identify compliance risks and escalate when necessary
• Strong sense of urgency
• Demonstrated interpersonal skills including strong negotiation skills
• Excellent teamwork and coordination skills
• Excellent verbal and writing skills and fluent in English and as applicable, local language is desired

Core Competencies / Skills

• Critical Thinking
• Investigation and problem solving
• Strong communication and stakeholder management skills
• Ability to influence and work effectively with local cross-functional team
• Agility and ability to manage complexity & balance priorities
• Risk identification, evaluation, and management.

Leadership Behaviors

• Enhanced enterprise thinking, finding innovative ways to serve patients build reputation and trust.
• Creating an environment that inspires and enables people.
• Focusing on the few priorities and provide superior results.
• Elevating capabilities for now and the future.

Locations

IND - Gurgaon

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time