ResponsibilitiesMay begin to work at the Product/Program level assignments under the guidance of a senior GSD statistician. Independently take on responsibilities for delivering on assignments with quality and within timelines. May oversee contingent workers and/or vendors; may provide training to others. May take on responsibilities for statistical aspects of study designs (sample size planning, endpoint assessment, etc.) and data analyses with the guidance of a senior level GSD statistician. Prepares, or oversees the preparation of statistical sections of clinical protocols in collaboration with their supervisor or a senior level GSD statistician. Writes or may oversee the writing of statistical analysis plans with an appropriate level of guidance. Support or may oversee the support of statistical analyses for the writing of clinical study reports, abstracts, manuscripts, and other documents for the marketing of Teva products Performs statistical analyses in line with the strategic plans for global regulatory submissions, such as briefing packages, integrated analyses, and regulatory responses. Collaborate with outsourcing partners and may oversee the statistical aspects of outsourced studies, as appropriate. Identifies processes that may require improvement and communicates this to GSD management in an appropriate manner. Participates in department initiatives to further the effectiveness of global statistics. Begins to evaluate and possibly implement innovative clinical trial design and analysis that are appropriate in adding value to the clinical development program. Qualification & ExpeirencePh.D./MS in Statistics/Biostatistics (or related field). MS with a minimum of 4 years of related experience; PhD with a minimum of 2 years of related experience. Provides independent statistical support to clinical studies with the guidance of senior level statisticians (i.e., Associate Director or higher). Provides sample size planning in accordance with the study design and analysis. May provide study design input and consultation for study endpoint assessment. Must exhibit situational awareness in considering innovative clinical trial design and analysis. Independent contributor to assigned studies under moderate supervision. Tackles difficult problems; Identifies possible solutions; and works with his/her supervisor for appropriate resolution. 

Responsibilities  Review of Master Documents Review and maintain Master Batch Manufacturing Records and Master Batch Packing Records to ensure accuracy, regulatory compliance, and alignment with approved specifications and process related changes. Coordinate with Production, QC, and Regulatory Affairs for timely updates and approvals. Annual Product Quality Review (APQR) Prepare, compile, and review Annual Product Quality Reviews (APQRs) in line with regulatory expectations. Support identification of improvement opportunities and follow-up of CAPAs arising from APQR findings. cGMP Training Coordination Coordinate and monitor cGMP and quality-related training programs for site personnel. Maintain trainingschedules, records, and effectiveness assessments. Archival & Records Retention Manage the archival room and document storage systems for controlled and historical GMP documents. Ensure secure storage, easy retrieval, retention compliance, and protection against unauthorized access or damage. Support audits and inspections by ensuring availability of archived records.Qualification & ExperienceBachelor’s or master’s degree in pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline. Experience 1–5 years of relevant experience in Pharma Quality Assurance / Documentation

Responsibilities Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods and other samples for Pharmaceuticals. Performing analysis of market complaints, Stability, process validation samples, Cleaning Validation of Pharmaceuticals. Good Laboratory PracticePerforming calibration & maintenance of lab. Equipment and assisting for the qualification of laboratory equipment.Managing reference standards, working standards, laboratory reagents & chemicals.Arranging and observing Control Samples and maintaining record.Participating in Investigation of out of specification results, performing retesting.Maintaining laboratory raw data related to testing activity ValidationPerforming the validation exercise as per the protocol. Maintaining raw data related to validation. Management of laboratory ConsumablesIdentifying and planning requirement for laboratory consumables and monitoring the stock of chemical, spares, glassware and printed material.Qualification & ExperienceBachelor’s or master’s degree in pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline. Experience 1–5 years of relevant experience in Pharma Quality Assurance / Documentation

ResponsbilitiesDeveloping and ensuring compliance with quality plans and programs  Coordinating regulatory inspections under the manufacturing and wholesale distribution licenses  Implementing regulatory compliance in cooperation with the Regulatory Affairs Manager  Monitoring of Group quality standards and their implementation in the local QMS  Recording and initial assessment of reported cases of drug risks or suspected cases where pharmaceutical-technical defects are involved  Collaboration and point of contact for Customer Service/KAMs/Medical Information and other departments regarding complaints.

ResponsibilitiesProvide subject matter expertise to teams to develop global strategies for the disclosure of clinical documents in accordance with applicable regulatory requirements. These requirements include, but are not limited to, EMA Policy 70, EU Clinical Trial Regulation, Health Canada Public Release of Clinical Information Guidance, and pertinent company policies/SOPs. Manage planning and preparation activities for disclosures. Drive quality in information, consistency across disclosures and related areas (eg, publications and data sharing), and completion of disclosures in a timely manner. Oversee vendors assigned to disclosure deliverables. Forecast and track outsourced disclosure deliverables. Act as the Pfizer point of contact to vendors, develop performance metrics, and participate in governance meetings. Promote open communication regarding project status and issue resolution. Lead development of standard processes and/or implementation of technologic solutions to enable compliance with disclosure requirements. Represent Medical Writing on clinical trial disclosure governance committees. Contribute to development of core expertise in disclosure and related fields within Medical Writing group by maintaining knowledge of regulatory guidelines and requirements as well as industry trends and best practices.Qualification & ExperienceAt minimum Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred. BS/BA with extensive experience, MS/MA with strong experience, PhD with strong relevant experience in the pharmaceutical or biotech industry. Experience with regulatory medical writing and preparation of EMA Policy 70 submissions required. Knowledge of data and/or document anonymization strongly preferred. Excellent project management skills to organize work and handle multiple projects at the same time. 

ResponsibilitiesEvaluate and review commercial drug batches to ensure compliance with established specifications. Ensuring Zero Defect Technology transfer for new product transfers into site. Quality Support and review of Scale-up, pilot bio batches and exhibit beaches to meet regulatory expectations. Reviews of Process validation protocols and reports to meet regulatory expectations. Review of Optimization Report /Technology Transfer Report, Analytical Data Sheet and Stability Data. Responsible to manage New Product Introduction (NPI) projects. Review and approval of Project validation protocols, QRM’s, Cleaning validation protocols and reports, process validation protocols & reports, Filter validation protocols & reports. Review of Analytical Method Transfer and method validation Reports and ensuring the key changes mentioned in the other transfer sites. Continuous improvement of templates for presentations, timelines, trackers, and other tools, Review , approval and ensure the compliance of SOPs related to technology transfer . Review and approval of validation protocols , PRQs and PR’s to ensure validation life cycle . Support production related documents review and approvals Approve investigations and change control activities to maintain compliance with configuration management policies. Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts. Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed. Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards. Qualification & ExperienceQualification : B.Pharm /M. Pharm/M.Sc Experience : 6 to 7 years of experience in sterile injectable technology transfers/ quality Assurance /validations. 

ResponsibilitiesChange Management process Risk assessments principles and tools Validation of manufacturing equipment’s Drug Product Process validations Regulatory requirements Advanced Competencies:Strong Interpersonal skills Ability to communicate effectively with all levels within the organization. Compliance driven approach , knowledge on cGMP and regulations. Knowledge in validation principles and practices related to the Equipment & Utility Qualifications, Water system, HVAC system.  Understanding of Drawings and layouts of manufacturing area, air flow, material flow, personal flow, building management system for real-time monitoring of manufacturing areas.  Fundamental knowledge on manufacturing activities like dispensing, solution preparation , filling, terminal sterilization, visual inspection, labelling and packing.  Understanding of design and engineering aspects, basic knowledge of equipment construction, working principle and maintenance of equipment.  Knowledge of various Quality tools required for investigations  Technical Writing- Ability to create documentation that is accurate, complete, unambiguous, and as concise as possible aimed to be understood by any level of organization.  Knowledge in Change control assessment Qualification & ExperienceB.Pharm/M.Pharm/M.Sc Experience: 6-8 years of experience in Validation/Maintenance / Engineering/ Quality.

ResponsibilitiesAs Tech Lead or Change Owner, define, organize, plan and execute activities related to product design change and new product registration in compliance with current international/regional/national regulations with minimal support of senior colleagues or independently. Provide technical assessment for product changes related to design, labeling, raw material, manufacturing support, regulatory compliance, quality improvement and new registrations in collaboration with senior scientists Lead, and coordinate - including follow-ups as required with global stakeholders - of technical activities in collaboration with key stakeholders, with respect of project commitment, quality procedures and business needs. Provide technical information, &/or prepare reports based on internal or external data available to formulate response to authorities’ questions Propose options, work closely with stakeholders and develop action plan for problem-solving, product and process improvement Establish, maintain and update technical & Design documentation according to Good Documentation Practices Participate in and at times lead multi-functional and international project team for effective collaboration and deliverables Demonstrate excellent internal and cross-functional communication and provide regular status update of activities to senior management & stakeholder with some supervisions from direct manager and senior members of the organization. Draft technically accurate reports with in-depth analyses as required using statistics or other relevant tools and mentor/coach help junior members to create information that can go into such reportsQualification & ExperienceMaster’s in Chemistry or Pharmacy (or related disciplines) with minimum 4 years of relevant experience, or PhD in chemistry or Pharmacy (or related disciplines) with experience in Pharmaceutical product development and life cycle management, preferably sterile injectable/parenteral formulations. Demonstrated ability in clear and effective communication (written, oral) and presentation skills to global stakeholders Excellent stakeholder management (local and global) A proven track record of leading small size projects – especially Change Controls in Pharmaceutical industry Demonstrated ability to work in a matrix environment with multiple stakeholders A proven track record of effectiveness in a fast-paced environment working in global teams Proven ability to deliver results by owning & being accountable for budget, timeline, and product/project deliverables

ResponsibilitiesIndependently lead end-to-end formulation development and process design for personal care products across formats (creams, lotions, gels, deodorants, body oils, cleansing) Drive fast-track NPD ensuring OTIF timelines and First-Time-Right (FTR) commercialization Translate marketing concepts and consumer insights into technically feasible, cost-effective, and scalable formulations Manage multiple projects simultaneously, ensuring timely delivery and stakeholder alignment Perform technical scoping including literature review, benchmarking, ingredient selection, and formulation strategy Apply DoE and scientific approaches to optimize formulations for performance, stability, manufacturability, and cost efficiency Conduct trend mapping and competitive intelligence to drive innovation and differentiation Identify opportunities and drive innovation, cost optimization, and sustainability initiatives Execute formulation trials, stability studies, and product evaluations considering performance, cost, packaging, regulatory, and safety requirements Lead pilot batches, scale-up, and technology transfer in collaboration with manufacturing and supply chain teams Collaborate with cross-functional teams (Marketing, QA, Analytical, Regulatory, Procurement, Supply Chain) and manage external stakeholders (vendors, third-party manufacturers, labs) Ensure compliance with GLP, GDP, regulatory, and internal quality standards, maintaining audit-ready documentation Create product demos and technical tools to support business and product understanding Draft and validate product claims based on formulation and ingredient functionality, ensuring regulatory alignment Act as a technical partner to marketing, supporting Key Visuals (KV), A+ content, and product storytelling Drive continuous improvement in safety, processes, and operational efficiency Maintain accurate documentation and digital systems for project tracking and data management

ResponsibilitiesExecute smooth technology Transfer and or Scale-up of acquired or developed formulation products into and out of company Work with third party agencies for development and validation. Support in preparation, technical evaluation of RFP, Customer Visits and Product Testing. Prepare and review documents related to technology transfer such as protocols, BMR, reports, TTD and PDR, formulation related SOP’s i.e. instruction manuals. Interact and support cross functional team such RA, QA, micro and clients Research, design and evaluate materials, assemblies, processes and equipment. Pharmaceutical development for new or identified product Develop Plan, coordinate and manage /execute laboratory pharmaceutical development activities in coordination with team members. Show pharmaceutics proficiency and use advanced analytical techniques to develop drug product. Perform complex experimental tasks including new techniques, procedures and equipment and propose experimental program and discuss with manager. Prepare project budget and schedule, proposals by collaborating with other stake holders. Track project progress periodically and achieve project goals. Business support Troubleshoot & or improve existing processes at the manufacturing sites Understand customer expectations on to-be manufactured product. Research, evaluate and assess feasibility of projects and provide feed back Acquire and document existing and elaborated knowledge. Qualification & ExpeirneceMasters in Pharmacy Strong Knowledge and understanding of the Pharmaceutical development and technology transfer with 12 - 15 years of industrial experience specially in sterile injectable products.