Job Description

Who we are

Together, we\'re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It\'s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world\'s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization\'s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we\'re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

• Qualification Engineer is responsible for managing and executing qualification and validation program for new and existing facilities within Goa Operations.
• Responsible for overall QAE oversight includes but not limited to, all the brown field (new) expansion projects, capacity expansion of existing facilities and support facilities such as New manufacturing & packing Lines ,new Equipments, New laboratory system - which should comply with Teva Quality Requirement ,global regulatory requirements, industry best practices and will withstand regulatory inspections.
• Demonstrate active participation in driving and developing strategies for continuous improvement of validation and qualification activities.
• Lead Harmonization of the manufacturing equipment, systems, facilities & utilities qualification program and shall provide independent QA oversight for these activities.
• Effectively collaborate with all levels of internal customers within Quality, Safety, Production, QC, Supply Chain, MS&T, CFTs for Quality assurance, Equipment Qualification Validation, Facilities QA compliance, Engineering, Manufacturing.
• This role will assist Associate Director Engineering for engineering qualification, Validation Compliance & QMS Governance for department.

How you\'ll spend your day

• Responsible for Preparation, Review & approval of validation, qualification, revalidation, requalification protocols/ reports.
• Review of facility layouts for Personal /material/waste flows/others, risk assessment, gap analysis & mitigation preparation.
• Identifying opportunities for process improvement and implementing best practices to enhance the overall efficiency and effectiveness of validation and qualification processes.
• Developing and executing validation and qualification plans based on regulatory requirements and industry best practices.
• Lead preparation and execution of URS preparation, Quality review, Inspection, Protocols (IQ, OQ, PQ), FAT, DQ, Performance evaluations, facilities design, Manufacturing Equipment for process critical systems.
• Creating detailed validation protocols that outline the specific tests and activities to be performed.
• Identifying potential risks associated with equipment, processes, or systems and implementing risk mitigation strategies to minimize the likelihood of errors or deviations.
• Ensure commissioning and qualification Schedule are adhered to and deviations are highlighted / escalated at right point.
• Lead & Support engineering team in order to assess and provide inputs in all required QMS elements viz. Change controls, deviations, risk assessments etc.
• Identifying potential risks associated with equipment, processes, or systems and implementing risk mitigation strategies to minimize the likelihood of errors or deviations.
• Follow site commissioning and qualification schedule, ensure that the engineering team follow & comply cGMP, GDP and GEP practices.
• To provide quality oversight and quality critical inputs for setup and commissioning of new facilities, expansion of facilities .
• Review and support assessments related to new equipment introduction. Based on the assessment to decide the qualification deliverables for assessed systems and equipment.

How you\'ll spend your day Contd...

• Participate in vendor discussion as part of negotiations for quality, GEP and GMP aspects.
• Maintaining comprehensive records of all validation activities, test results, deviations, and corrective actions taken. Preparing validation reports to summarize the findings and outcomes of the validation process.
• Support project team in execution of projects throughout project life cycle from initiation to close out.
• Working closely with cross-functional teams, including quality assurance, engineering, production, and regulatory affairs, to ensure that all aspects of validation and qualification are addressed properly.
• During project execution will focus on compliance to current industry best practices, safety and schedules, while complying to GEP, company policies, regulation and codes.
• End to end Handling of projects for commissioning, validation and qualification for Goa Operations.
• Prepare initial system assessments and review qualification lifecycle deliverables for typical systems
• Ensure while execution and preparation of qualification documents Quality, Safety, and technical compliance in the engineering function in accordance with new or changing environmental policies, standards, regulations.
• Ensure on-time Deviation, CAPA, CC, SOP revisions, Training closure, Risk Assessment, Gap Analysis, RPN evaluations etc.
• Monitoring & Governance for on-time Equipment Qualification & Handover of Projects.

Your experience and qualifications

• Bachelor\'s degree in Engg in any stream / bachelor\'s degree in Pharma - Experience in Pharma/Lifesciences/FMCG experience in documentation/compliance with 4+ years experience.

Teva\'s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva\'s global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Teva Pharmaceuticals