ResponsibilitiesReview external GMP batch documentation from CDMO partners for completeness, accuracy, and compliance with approved manufacturing and regulatory requirements. Evaluate analytical data, Certificates of Analysis (CoA), and laboratory documentation to ensure data integrity and GMP compliance. Support Quality oversight of external manufacturing activities, including preparation for batch disposition. Identify documentation inconsistencies, deviations, and potential compliance risks, ensuring timely escalation to Quality stakeholders. Collaborate with internal teams (QA, QC, Supply Chain) and external CDMO partners to resolve documentation queries and ensure alignment. Generate and maintain Key Quality Indicators (KQIs) to monitor external manufacturing quality performance. Ensure adherence to Lonza Quality Standards, data integrity principles, and global/local GMP regulations. Qualification & ExperienceBachelor’s degree in Chemistry, Biotechnology, Pharmaceutical Sciences, or related field. Experience in GMP-regulated pharmaceutical, biopharmaceutical, or CDMO environments is advantageous. Understanding of GMP documentation, batch records, and data integrity requirements. Strong attention to detail with the ability to review complex documentation accurately. Effective communication skills with business fluency in English. Ability to work cross-functionally with internal teams and external partners. Organized, proactive, and able to manage multiple priorities in a fast-paced environment.

Qualification & ExpeirenceGraduated / post-graduate in Pharmacy/Medicine or Chemistry/Biotechnology 3 to 6 years minimum experience in Quality or Regulatory Affairs Experience obtained in pharmaceutical manufacturing sites (+3 years). Knowledge of stability regulations and its application to the industry Skilled in the usage of IT tools (for example: Quality Forward, Share/DrugTrack, eDMS), SAP. English speaker Good organizational skills, stress resistance, and flexibility Good Team player and good in decision-making Interpretation/Analytical data. Experience in the pharmaceutical/biotech industry with a good level of GxP know-how is a strong plus.

ResponsibilitiesQualification and Validation of instruments/equipment’s  Appropriate training and guidance to the subordinates. Safety in the laboratory. Regular housekeeping and upkeep of the work area. Maintaining adequate inventory of chemicals and reference standards. Adapting relevant technologies and systems in Quality control. Laboratory equipment calibration and their maintenance. Generate up gradation plans as need basis.

ResponsibilitiesSupporting in-process control sample testing by online analysis to support production activities Sampling, analysis and ascertaining quality of intermediates, In-process samples and API for ChemiAnkleshwar.Testing of the method validation samples and process validation samples and cleaning validation. Perform analysis and documentation of API finished product stability study as per stability study protocol. Coordinating with Production, CWH and QA for Approval / Rejection of raw materials/finished product.

ResponsibilitiesKnowledge on testing bacterial vaccines testing such as Typhoid conjugate vaccine, Diphtheria bulk testing, Tetanus bulk testing and Td vaccine testing is highly preferrable. Experience in handling HPLC, Dionex, UV-Spectrophotometer, Multimode plate reader and ELISA Shall be well versed with Biochemical assays (Protein, O-acetyl) immuno-chemical assays and electrophoresis, Knowledge in calibration and qualification of equipment and instruments. To perform/ monitor activities in compliance with GMP/GLP/GDP and record keeping. Experience in preparing SOPs, Specification, STPs and Study protocols To prepare method validation protocol and execute method validation. Experience in handling stability studies and maintaining records. Role shall require to coordinate with engineering/ maintenance department or third party labs as and when required. Should possess basic skills in MS-Office, LIMS & SAP Knowledge of regulatory guidelines from WHO, CDSCO, and pharmacopeias are added advantage.

ResponsibilitiesMedical Device Medical Writing Medical Writing - Authoring, updating, and reviewing, medical device focused documents in Regulatory and Safety Space Clinical Evaluation Plans (CEP)/ Reports (CER) Post-Market Clinical Follow-Up (PMCF) plans/reports Clinical Investigation Plan (CIP)/Protocol Clinical Study Reports (CSRs) Summaries of Safety and Clinical Performance (SSCP) Informed Consent Documents (ICD) Investigators Brochure (IB) Periodical Safety Update Reports (PSUR) Publication and white papers Health Hazard Analysis (HHA) / Evaluation (HHE) or Public Health Threat Analysis (PHTA) for Medical Device complaints Individual Case Safety Reports Narratives Other pertinent documents Literature Science: Literature search strategy, conduct, summary and reports Preparation of Literature search protocol and search strategy Conducting systematic literature searches to gather clinical data, evaluating evidence, and extracting data for inclusion in reports Preparation of Literature summary reports and Literature-based documents such as SotA Qualification & ExperienceEducation: Medical Graduation – only MBBS or BHMS candidates may apply. Exceptionally good Pharm D candidates who have exposure and understanding of Medical Devices may be considered. Experience: 0-3 years of experience in Medical Devices Safety Functions or Medical Writing

ResponsibilitiesResponsible for the MSTG-NOSD activity related Technology transfer of new products, site transfer products, commercial launches, LCM activities and CMO activities. Responsible for establishing new procedures, maintaining and updating existing procedures in the MSTG NOSD department. To co-ordinate with Cross Functional Team for execution of Trial, Scale-up, Exhibit, Process validation batches of new Products and commercial launch batches. Responsible for Support in regulatory Audit and Compliance & Query responses for Filed products. Handling & Support of Trouble shooting batches for data comparison and route cause Investigation for commercial products. Responsible for Review, comments and approval of MF, FMEA, RA, BMR & protocol (Sampling plan, Process validation protocol) and other technology transfer documents. Responsible for technical evaluation of new process technology in coordination with procurement team and finalization of User requirement specification. Technical support to plant operations team for upgradation to newer process technologies and better sterility assurance. Technical support for improvement in product robustness. Development of new vendors for process technologies. Responsible for overall development and training of the team members. To ensure compliance to cGMP and documentation for various packing activities.Qualification & ExperienceQualification B.Pharm / M.Pharm Experience Tenure : 10-13 Years ( Pharmaceutical Industry experience with Injectable formulation site) 

Responsibilities  Administrative & Documentation Support  Maintain, update, and organize Trial Master File (TMF) and Investigator Site File (ISF)  Ensure essential documents meet ICH-GCP, regulatory, and sponsor requirements  Track and manage study documents, versions, and approvals  To update and maintain all study related trackers.  Study Coordination  Assist the clinical operations team in planning, initiating, executing, and closing clinical studies  Support Clinical Research Associates (CRAs) with site management tasks  Help with study tracking (enrolment status, visit schedules, monitoring reports, etc.)  Assist in tracking invoice generation and payment process for all sites, clinical studies, ECs, data management vendors, etc. and maintain respective payment trackers  Perform vendor code generation and tracking of vendors.  Communication & Liaison Qualification & ExperienceMinimum qualification requirement is to have Bachelor's or Master's degree in a field related to Science, Healthcare, Clinical Research or Life Sciences like Biology, Pharmacology, Nursing, or a related discipline, and/or Post-graduate Diploma in Clinical Research Experience 1-2 years in Clinical Research/Clinical Research Coordinator (Hospitals)

Responsibilities Development of marketing and promotional plans for products to support the end consumer’s need  Monitor business performance and support the portfolio with the help of regular tracking  Market intelligence through primary research and customer connect  Writing and executing strategic business and marketing plans in collaboration with important prescribers, opinion leaders, round tables, and other advisory groups  Joint financial responsibility for budgets (advertising and promotion, conferences and symposia, sales brochures and other product documentation, website content, literature), as well as analysis of budget income and costs; initiating and coordinating marketing activities and projects  Presentation to staff and training field staff for the same  Visiting national and international congresses, hospitals, and key opinion leaders (KOLs);  Translating the corporate brand strategy in close collaboration with headquarters, together with logos and visuals, working with corporate product budgets (approval for expenditure on projects, local communication strategies), and providing input into corporate product strategy.  Managing end-to-end projects related to new product introduction (NPI), new category assessment, and go?to?market (GTM) strategies, ensuring cross-functional alignment and timely rollout  Driving Direct-to-Consumer (D2C) initiatives and Patient Support Programs (PSPs) to enhance consumer engagement, patient adherence, and brand experience  Designing and executing lead?generation strategies through digital, on-ground, and partnership channels to fuel the customer acquisition funnel and improve conversion metrics  Discussion partner for first, second, and third-line professionals such as general practitioners, medical specialists, pharmacists, and other medical professionals, and for other DMU members (decision-making units) such as local and national formulary committees and insurance companies;  Organizing advisory councils, acting as a discussion leader or chairman, or giving product presentations.  Collaboration with internal & external media to ensure the proper execution of strategiesQualification & ExpeirenceM.Sc / B.Pharm / M.Pharm Experience Tenure : 8-10 years

Qualification & Experience                           Criteria : 2 Years Exp.                            Qualification : GNM