ResponsibilitiesTo perform advanced characterization of complex injectable drugs, including iron formulations, proteins & peptides, oligonucleotides, carbohydrates & other biomolecular APIs and various impurities in lyophilized, liquid, emulsions & other formulations for regulatory submission following GLP norms.To manage outsourced studies at CROs, academic institutes & other external facilities, from study design, execution, analysis and report preparation. Traveling to external facilities, as and when required, is a mandatory requirement for this position. To demonstrate subject matter expertise and help overcome technical challenges in product development, by liaising with formulation and other cross-functional teams as a Subject Matter Expertise (SME). To understand the project with guidance of Sub-department Manager and follow their instructions. To provide necessary assistance for various procurement activities, review quotations, engage suppliers to procure required goods & services in a timebound manner To complete the planned work in the stipulated time frame, inform the Sub-department Manager if any deviation or issues are observed. To keep track of each activity related to product analysis and development activities. To carry out all the testing and data recording according to the approved SOPs/ ALCOA++ principle and current pharmacopoeia. Data recording in ELN and sign off must be completed on time.Qualification & ExperienceMasters (Pharmacy, or equivalent discipline) with 6 to 10 years of experience, or, PhD (biophysics, biochemistry or equivalent discipline) with 0 to 5 years of experience in SEC-UV-MALS and related methods encompassing liquid chromatography, light scattering, diffraction and light obscuration

Responsibilites  Media fill and qualification summary preparation knowledge.  To maintain track of qualification and validation activities.  To prepare and review the protocols and reports. Execution of various qualification / validation activities.  To review correctness of the technical documents received from the supplier (DQ/OQ/IQ/PQ,FAT).  Co-ordinate with production and other user department for qualification/validation activities  Timely compile and review of qualification validation reports.  To review the equipment documents like calibration reports and ensure correctness of documents.  To perform FAT.  To co-ordinate with outside agencies for execution of qualification activity whenever required.  Identification of deviation through review and observation.  To prepare annual Re-qualification/validation schedule, update VMP and Qualification related SOPs as and when required.Qualification & ExperienceB. Pharm/ M. Pharm/ MSC. Relevant Skills / Industry Experience 2 to 3 years experience in USFDA, MHRA, TGA approved plant

Responsibilites To ensure the timely execution & oversee success of all pragram intervention at site. To align central leads on daily plan for each interventions. To oversee the success of quality circle work stream at site. Monitor the status of continuous improvement initiatives. Monitor the success of gemba walk at site. To conduct quiz collect the data & resolving bottleneck issue.Qualification & ExperienceB.Pharmacy Relevant Skills / Industry Experience Experience in QMS, Regulatory exposure& data analytics. USFDA exposure is must. Minimum 10 Years Experience Required.

Responsibilites Domestic regulatory filing and approval. Submission of registration dossier/s as per MOH requirements initially in countries, to explore further in different markets as per managements decision. Review/Gap analysis of the existing versus US/EU regulations & dossiers as per ICH guidelines, country specific requirements. Maintain current knowledge of relevant regulations for registrations in International markets. Coordinate with regulatory activities such as international audits & regulatory agency inspections, product recalls. Planning dossier submission timelines in coordination with QA.Qualification & ExprienceM.Pharm ( RA / QA ) Relevant Skills / Industry Experience 10-15 Years in Regulatory/ Compliance Related Activities

ResponsibilitiesReceipt, registration and upkeep of all the samples/standards/excipients in the laboratory. Perform analysis as planned in the individual sections to adhere to the schedules and meet the commitments made by the individual sections. Analysis to be performed based on the qualification matrix of the analyst. Timely and error free documentation as per the GLP requirement. Perform Glorya related activities. Calibrations of Laboratory Instruments and Equipment. Preparation of reagents and standardization of volumetric solutions. Submission of approved reports to Quality Assurance. Responsible for SAP related activities. Handling of Trackwise harmony system for trackwise related activities. Revision and updation of Standard Operating Procedures, test methods and specifications. Analysis and reporting of results in LIMS software.Qualification & Experience4 to 7 years M.Sc Chemistry

ResponsibilitiesEnsure compliance with all applicable cGMP directives, regulations, and guidelines to maintain the high quality of pharmaceutical products. Lead and oversee deviation investigations, ensuring compliance with Teva corporate procedures and local quality procedures. Perform impact and risk assessments for critical quality events. Assess and categorize deviations and determine the impact on affected batches. Coordinate with Teva affiliates regarding deviations that may affect product deliveries. Review and evaluate deviation reports from contract manufacturers, assessing their potential impact on the batch release process in collaboration with the responsible Teva release QP.Qualification & ExpeirenceExperience in pharmaceutical manufacturing/validation/other related experience and/or in analytical control and regulatory compliance Master’s degree in pharmacy, chemistry, similar natural sciences, engineering or at least several years working experience in the quality assurance area Understanding of the drug manufacturing process. Knowledge of generics and branded product development is a plus Good interpersonal and communication skills, as well as organizational skills Ability to communicate complex issues, decision-making, problem-solving skills Proficient in written and spoken English Proficiency in MS Office, SAP, Veeva

ResponsibilitiesReceipt, registration and upkeep of all the samples/standards/excipients in the laboratory. Perform analysis as planned in the individual sections to adhere to the schedules and meet the commitments made by the individual sections. Analysis to be performed based on the qualification matrix of the analyst. Timely and error free documentation as per the GLP requirement. Perform Glorya related activities. Calibrations of Laboratory Instruments and Equipment. Preparation of reagents and standardization of volumetric solutions. Submission of approved reports to Quality Assurance. Responsible for SAP related activities. Handling of Trackwise harmony system for trackwise related activities. Revision and updation of Standard Operating Procedures, test methods and specifications. Analysis and reporting of results in LIMS software.Qualification & Experience4 to 7 years M.Sc Chemistry

 Responsibilities Initiate Master Manufacturing Records (MMaRs) & Master Packaging Record (MPaRs) Initiate Placebo and Optimization batch record for trails. Initiate Change Controls in QMS Track Wise for New Launch / Site Transfer / Submission batch / SOPs / Formats and commercial batch documents. Ensure QMS Change control closure within the stipulated timeline. Ensure support for timely completion of Investigations for document related deviations and document revision based on CAPA. Initiation of batch documents , SOPs and Formats in Content server. Check Monthly Schedule to ensure document readiness. Ensure all changes are aligned with cGMP regulations and corporate SODs. Perform all work in accordance with established regulatory, compliance and safety requirements. Coordinate with NPL and RA regarding Deficencies from Regulatory Agencies and Clarifix. Develop and maintain effective working relationships with internal and external customers. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies and HR policies. All other relevant duties as assigned.Qualification & ExperienceMinimum Bachelor of Pharmacy / Science or any equivalent degree. Experience Minimum 1 year of experience in GMP regulated pharmaceutical industry.  Knowledge, Skills and Abilities Adequate knowledge in handling QMS Trackwise tool, Content server tool. People management skillset Adherence to cGMP

 Responsibilities Answer phone calls and redirect them when necessary Manage the daily/weekly/monthly agenda and arrange new meetings and appointments Prepare and disseminate correspondence, memos and forms Support and facilitate the completion of regular reports Develop and maintain a filing system Make travel arrangements Document expenses and hand in reports Preparing financial statements, reports, memos, invoices letters, and other documents. Handling basic bookkeeping tasks. Filing and retrieving corporate records, documents, and reports. Researching and conducting data to prepare documents for review and presentation by boards of directors, committees, and executives. Helping prepare for meetings. Accurately recording minutes from meetings. Greeting visitors and deciding if they should be able to meet with executives. Using various software, including word processing, spreadsheets, databases, and presentation Reading and analyzing incoming memos, submissions, and distributing them as needed. Performing office duties that include ordering supplies and managing a records database. Experience as a virtual assistant. Opening, sorting and distributing incoming faxes, emails, and other correspondence. Provide general administrative support. Any other duties/tasks as and when assigned by the Director/Site Head This job includes participating in selective reviews with VP- Product Supply and taking minutes, follow up on closing the actions with all stakeholders Making sure company policies and well adhered too. Need to be well versed with SAP system.Qualification & ExperienceMinimum of Graduate Degree in related field. Knowledge, Skills and Abilities Proven work experience as a secretary, executive assistant or administrative assistant Familiarity with office organization and optimization techniques High degree of multi-tasking and time management capability Ability to Organize a daily workload by priorities Must be able to meet deadlines in fast-paced quickly changing environment A proactive approach to problem-solving with strong decision-making skills Excellent written and verbal communication skills Integrity and professionalism Proficiency in MS Office and Power points

 Responsibilities Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned To be well disciplined & maintain the same in the production department. To maintain the safety and housekeeping practices at work place. To ensure and follow good and online documentation practices. To ensure proper labeling procedure wherever applicable as per procedure. To ensure that cleaning the area as per related SOP ‘s are conducted and maintained as per proper cleanliness. To ensure the Calibration/Preventive maintenance of the equipment as per the schedule. To maintain and ensure cleaning and operation activities are performed as per procedure.Qualification & ExperienceB.Pharm Knowledge, Skills and Abilities Adequate knowledge and ability in handling /supervising the manufacturing activities In depth knowledge of cGMP practices Identify and escalate equipment related issues. Experience 14 years 8 months