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Senior Executive | Analytical R&D | Pfizer India | Chennai

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Position: Sr Executive – Analytical R&D

Location: Chennai, Tamil Nadu, India

Job Description:

ROLE SUMMARY

  • The purpose of this function is to perform Analytical R&D activities such as method development, method validation, method transfer, in-process/complete analysis, and stability study.
  • He / She shall perform other essential duties as and when required/assigned.
  • To adhere to both quality and safety compliance according to organizational policies/procedures and regulatory guidance.

ROLE RESPONSIBILITIES

  • This position will also hold the responsibility to identify and champion the implementation and harmonization of technical programs/projects related to improving and/or contemporizing new technologies applicable to analytical methods.
  • Perform assessments of existing data packages, feasibilities, and conclude remediation.
  • Carry out spectroscopic characterization and verification process of the materials through consistent and effective use of Pfizer SOPs/Tools.
  • Ensure technical output is compliant with all Global Training Curricula for the instrument operations, material handling, and certifications related to, Quality Ops, Manufacturing, and EHS.
  • Collaborate with QTS MIR/LIR user council representatives to identify opportunities for system improvement.
  • Communicate planned changes if any related to QTS users.

  • Work with the Quality Assurance and other cross-functional teams to facilitate the consistent, disciplined execution of the LIR/ER/CAPA quality system ensuring the completeness and comprehensiveness of the assigned task.
  • Review and analyze corrective and preventive actions’ effectiveness through appropriate tracking and trending methods in order to prevent the reoccurrence of issues.
  • Engage in method robustness program by contributing in gap assessment, remediation, and analytical method validations.
  • Ensures compliance with local and corporate procedures and ensures all data packages are audit ready and transferable.
  • Perform the peer review of draft data packages submitted by other analytical team members.
  • Ensure appropriate GT&E LT review of the formal reports that are considered milestones for decision making.
  • Coordinate with cross-functional teams to ensure timely execution and resolution of all deliverables versus target milestones.

Desired Skills & Competencies:

  • Minimum  Masters or Ph.D. in pharma, engineering, or  science discipline
  • Demonstrated technical capabilities with a successful track record of development, remediation, validation, and transfer of analytical methods.
  • Education and technical areas of expertise should include the majority of fields of analytical technologies, compendia, regulatory guidance, and current scientific developments.
  • Experience in analytical equipment and process qualifications and validation activities.
  • Strong decision making, critical thinking skills, and the ability to work systematically through complex issues.  Capability to make informed assessments of risk and independently develop risk mitigation strategies.
  • Proficient with the use of a variety of problem-solving (DMAIC), risk analysis, and statistical tools. Advanced OPex skills desirable, preferably with Pfizer Green/Black belt level certification.

  • Possess excellent communication skills and the ability to articulate complex issues clearly and concisely. Understands the importance of effective stakeholder management and communications.
  • Strong scientific skills and proven track record of being able to “lead from the front” and deliver timely solutions to complex problems.
  • Action bias and collaborative by nature.  Demonstrated track record of being able to work effectively across cross-functional boundaries.
  • Capability to make informed assessments of risk and independently develop risk mitigation strategies.
  • Ability to engage with colleagues and develop effective relationships across SM/GTE teams and stakeholders at all levels.
  • Decisive and action-oriented leader, with strong problem-solving and analytical skills.
  • The recognized scientists with the capability to influence both internally and externally.
  • Capable of independently developing and managing technical project plans, timelines, and deliverables across cross-functional teams.
  • Strong working knowledge of the Quality/GMP/ICH/compliance systems of the Drug substance/Sterile Injectable pharmaceutical industry and regulatory body’s requirements.

  • Possesses Tech writing competencies at level NLT 75% BEC score.
  • Possess in-depth technical expertise on products and technologies associated with the manufacturing or labs, and a thorough understanding of product and process and how manufacturing operations can influence product characteristics
  • Strong understanding of cGMP requirements, validation (process and/or analytical), and contemporary regulatory requirements and guidelines.
  • Demonstrated ability to plan, implement, and achieve complex goals and objectives.
  • Ability to manage complex technical details coupled with the ability to remain focused on the business needs
  • Strategically analyses the risks, benefits, and opportunities of various solutions and anticipates and considers the scope of impact a decision will have on other groups and the business unit
  • Often participates in projects that are more complex and may have considerable technical risk and assign priorities to multiple competing and important activities quickly and effectively.
  • Takes timely strategic actions in designing and leading groups to facilitate them working together effectively
  • Anticipates the impact of industry trends and develops strategic plans in the best interest of the business
  • Uses judgment, knowledge, and experience to define a project course of action, resources requirements, and priorities

BEHAVIOURS

  • Team player by preference with the proven ability to work independently across organizational boundaries.
  • Demonstrated ability to influence and negotiate across teams, sites, and organizational networks.  Ability to lead and influence at all levels of the organization.
  • Strong team player with a proven track record of managing and building relationships both within and across cross-functional teams.
  • Completer/finisher by nature with a strong history of delivery across multiple complex programs.
  • Self-starter, highly motivated individual, with an action bias and collaborative by nature.  Demonstrated track record of being able to work effectively across cross-functional boundaries.
  • Plays a major role in internal teams and in influencing external groups

Qualification: M.Sc/M.Tech/Ph.D.

Experience: 7-12 Years

Salary: Negotiable

Contact Details:

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