Assistant Manager QA

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Job title: Assistant Manager QA

Company: Takeda

Job description: By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s and . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Job Responsibilities:

  • To support in managing activities for Takeda in India to develop, implement and maintain a systematic, effective and efficient local Quality Management System (QMS) as per local regulatory authority and Takeda’s global requirements. The QMS includes but are not limited to: documentation creation, document maintainenance & control, Maintenance of logs, SOP writing, personnel training management, product release, product sample management, product complaint handling, change control, deviation/CAPA, quality improvement plan, gap assessments, 3PL activities support.
  • Knowledge of electronic QMS systems like Trackwise, Training systems and electronic documentation management system.
  • To provide quality oversight of GXP suppliers, customer and distributor qualification and lifecycle management. To Lead or participate Quality audits, & support QA due diligence of new business partners.
  • To manage Quality operations for Takeda in India 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. These activities include but are not limited to: Batch documentation review for importation, coordinating Local product testing (document, sample submission & on time payment to lab), product release in country (shipment temperature evaluation, necessary document review, release in ERP system), Redressing records review, document creation/maintenance, product transfer temperature data review and other documentation.
  • Provide support to ensure all KPIs for local quality operation for Takeda India meet the established requirements.
  • To visit 3PL warehouses and other suppliers for QA activities as and when required for Quality deliverables.
  • To support Quality Management Representative for Takeda in India to develop, implement and maintain a systematic, effective and efficient local Quality Management System (QMS) as per local regulatory authority and Takeda’s global requirements. These include but are not limited to: change control, deviation, CAPA management, training, document management, complaint handling, etc.
  • To perform quality activities and resolve quality issues for Takeda in India to support continuous supply of Takeda products in India in compliance to local regulatory authority and Takeda ’s global requirements.
  • Ensure all relevant quality support are provided for all relevant post market activities for Takeda in India and are executed timely as per local regulatory authority and Takeda ’s global requirements so as to minimize any product supply interruption.
  • To support in initiation of Notification to Management / escalation report for notifiable events in accordance with Takeda Global Procedure.
  • To support in executing local recall/market action once the decision is endorsed by Market Action Committee (MAC), and ensure timely completion of the required actions.
  • Other activities as assigned and emerged during routine Quality functioning.
  • Establish and maintain local risk register. Engage key LOC stakeholders to proactively identify GDP / GMP/quality risk areas, and establish appropriate risk mitigations and risk monitoring program at the LOC.
  • Ensure local Quality Council / Management Review is conducted on a regular basis.
  • Monitor key performance indicators, evaluates and highlights any significant trends and identifies actions.
  • To ensure self-inspection program at LOC is performed with timely completion of CAPAs, to evaluate compliance with product quality systems & processes at LOC, and to identify improvement opportunities.
  • Establish and maintain internal and external Quality Agreements.
  • Other activities as assigned and emerged during routine Quality functioning.

Education and Experience requirements :

  • Successful completion of relevant tertiary qualification – science Master degree.
  • Minimum 10-12 years’ experience in Pharmaceutical Company in quality function with 7-8 years in GMP manufacturing plant environment of sterile Pharmaceuticals, 3-5 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 Good Storage Practice (GSP) and Good Distribution Practice (GDP) and NMC corporate standards; Drugs and Cosmetics Act, Schedule M and WHO guidelines.
  • Good knowledge and experience on 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).
  • Sound knowledge and experience in working with cGMP and quality management system elements and guidelines (e.g. PIC/s, ICH, ISO9001 or ISO 13485) and cold chain product repackaging.
  • 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

Key Skills and competencies:

  • Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team leader or team member, share information and deliver results with a team
  • Execute goals and objectives in a driven and a high performance culture, and as applicable with ability to achieve results with non-direct reports
  • Organization agility (knowledgeable about how an organization works) and ability to apply that capability to lead change, deliver strong results and build the confidence of stakeholders
  • Able to work with a great degree of autonomy, as part of a global virtual team
  • Able to work cross-functionally and cross-culturally, in a global business environment
  • Ability to manage multiple and complex priorities, and to recognize when a change of priority is needed
  • Able to adapt to changes and positively respond to changes
  • Enthusiastic, resilient, dynamic, versatile. Display ‘Can do’ attitude
  • Good interpersonal and communication skills
  • Excellent verbal and writing skills and fluent in English and as applicable, local language is desired
  • Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following:

Leadership Behaviors * Be Positive

  • Be Accountable
  • Be Results Oriented
  • Enhance capabilities
  • Strive to drives the business forward and look for practical and compliant solutions to issues.
  • Understands total potential impact and contributes significantly to the solution of simple or complex issues arising
  • Expected to work with a number of suppliers / products
  • Provide a positive and solution oriented environment
  • Uses experience to facilitate troubleshooting, and to tackle non-routine work and projects independently
  • Offers constructive comments and proposes improvements and rationalizations to systems, policies and procedures
  • Uses own judgment to assess what to refer upwards and what to deal independently.

Locations

IND – Gurgaon

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Expected salary:

Location: Gurgaon, Haryana

Job date: Wed, 07 Sep 2022 00:05:03 GMT

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