Research Associate

Job Description

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 both quality and safety compliance according to organizational policies/procedures and regulatory guidance.ROLE RESPONSIBILITIESThis position will also hold responsibility to identify and champion 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 reoccurrence of issues.Engage in method robustness program by contributing in gap assessment, remediation and analytical method validations.Ensures compliance to local and corporate procedures and ensures all data packages are audit ready and transferable.Added knowledge of Performing 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.QUALIFICATIONS & COMPETENCIESBASIC QUALIFICATIONSMinimum master s in science or pharma disciplineDemonstrated 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.Having knowledge/proficient with the use of a variety of problem-solving (DMAIC), risk analysis and statistical tools.Possess excellent communication skills and ability to articulate issues clearly and concisely. Understands the importance of effective stakeholder management and communications.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 person, with strong problem-solving and analytical skills.Recognized scientist with capability to influence both internally and externally.Capable of involving in developing and managing technical project plans, timelines and deliverables across cross functional teams.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.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 needsStrategically 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 unitOften participates on projects that are more complex and may have considerable technical risk and assigns priorities to multiple competing and important activities quickly and effectively.Anticipates the impact of industry trends and develops strategic plans in the best interest of the businessUses judgement, knowledge and experience to define a project course of action, resources requirements and prioritiesBEHAVIOURSTeam player by preference with the proven ability to work independently across organizational boundaries.Demonstrated ability to influence and negotiate across teams, site and organizational networks. Ability to lead and influence at all levels of the organization.Strong team player with 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 groupsOTHER INFORMATION3-5 years of experience in pharma/chemical industry and possesses knowledge of API, sterile manufacturing or quality functions, chemical reactions to understand regulatory expectations and possess exceptional expertise in data interpretation and scientific outputsPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.,

Keyskills :
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