ResponsibilitiesTo Review of Executed BPR Maintaining the equipment logbooks, physical monitoring records, house keeping records and BPR and any GMP documents. Supervision and controlling of CPD First Floor (Block F) packing activity to meet delivery schedule. Work allocation to the operators and workers as per packing plan. Training provides to operators to achieve the target with minimum rejection, packing related activity, cGMP, GDP and SOP. Help the operators in to standardize machine operation to achieve better efficiency and quality. To take out all LMS related training through LMS (Learning Management System). To generate and retrieve all relevant formats through EDMS (Electronic Data Management System). To generate Process Order, Process Order Receipt, Material Return, CORO (Deviated) Issue, Packing List, Consumption order and all type of relevant labels and any other SAP HANA System related activity through SAP HANA System. To take out print and check Cold room and BMS system. To preparation of departmental SOP. Training provided to all officer, operator and contract workmen for implementation of SOP. Preparation and execution of qualification protocol of CPD First Floor (Block F) packing department. To preparation of departmental MBPR. Any other job assigned by the superiors to complete timely."Qualification & ExperienceB.Pharma / M.Pharma /MScExperience – 7+ years

Responsibilities GMP/GDP & MAH Compliance Support execution of MAH responsibilities as required under EU GMP and EMA MAH expectations. Maintain documentation and systems ensuring compliance for all branded products. Oversight of Outsourced Activities Maintain and update Qualification status for outsourced manufacturing/testing partners. Ongoing KPI’s monitoring with key CMO’s Periodical Risk assessment evaluated risks per CMO. Writing/compiling Annual product reviews for branded products Audit & Qualification Support Assist in planning and maintaining the audit schedule Collect audit evidence, and GMP confirmation documents in comprehensive archive. (optional) participate in CMO audits. Support in planning and inspections readiness for external audits (from partners, corporate quality systems and regulatory authorities) Unplanned deviations, Complaints & Recalls Log and coordinate complaint and quality defect investigations with manufacturers, and ensure their progression through the QMS to satisfactory and timely closure. Support in recall preparation, notifications, and documentation Support in deviation management documentation in QMS Track and follow up on CAPAs related to quality issues. Change Control Support Track manufacturing site change requests and support QA in evaluating GMP/MA impact Collaboration with cross departments Collaborate with cross ? functional departments, including Business, RA, and PVG, to gather necessary information as needed.Qualification & ExperienceBachelors or Masters degree (WO) in (Bio)chemistry, Pharmacy, Pharmaceutical Business Administration, Biotechnology, or a related Life Science field. Minimum of 5 years experience in a relevant pharmaceutical environment (manufacturing, QA/QC, regulatory operations, or contract manufacturing). Strong knowledge of EU GMP and US CFR requirements. Proficient in Excel and comfortable working with data and quality documentation. Fluent in English, both written and verbal.

ResponsibilitiesHelp in completing the budget of the region on time Analysis of the budget and provide insight to the CEO to take informed decision on budget Analysis of working capital target in the budget and compare it with previous year performance Monthly analysis of the actual P&L against budget and last year SKU wise analysis and recommendation on the rationalization Review of working capital of the region and provide insight to business for accounts receivable and supply chain for Inventory Prepare a quarterly review deck with the support function head

ResponsibilitiesLead the team of Vial Line Responsible for preparation, review, revision, control and implementation of standard operating procedures. Responsible for preparation & review of the master documents. Responsible for preparation and review of Protocols and reports based on the requirements. Responsible for Document management like BMR’s, BPR’s, Master SOP’s etc. Responsible for the handling of Change Control, Deviations, CAPA, Investigation etc. Responsible for line clearance activity before commencing the operations like manufacturing, filling, capping & packing operatTo generate general purchase indent for departmental general items. Responsible for preparation of production planning on monthly and also daily as per the requirement and availability of material. To generate general purchase indent for departmental general items. Responsible to prepare daily production report as per the production achieved. Responsible to ensure that all equipment’s and lines are in validated and calibrated status. Responsible to follow cGMP, GDP and discipline in the department and to ensure that all employees follow the same. Responsible to give training to all the subordinates, technicians and operators of the department. Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HOD’s instruction and guidance,, Responsible to attend the training as per training schedule and to ensure training as per16 Ensure the compliance & discipline on floor. Responsible to make shift schedule. Responsible to check that all the records and log books related to manufacturing, filling and sterilization of equipment’s.QualificationBachelor of Pharmacy / Master of Pharmacy

ResponsibilitiesMedical Strategy & Scientific Support Support the development and execution of medical affairs strategy for the Oncology therapy area in alignment with business objectives. Provide scientific inputs into brand planning, new product launches, and lifecycle management. Contribute to medical planning for assigned oncology products. KOL & Stakeholder Engagement Build and maintain relationships with Key Opinion Leaders (KOLs), oncologists, and academic institutions. Participate in scientific discussions and address medical queries. Identify opportunities for collaborative research and publications. Medical Education & Communication Develop and review scientific content for: Advisory boards CMEs / symposia Training programs Promotional and non-promotional materials Conduct training sessions for internal stakeholders including sales teams. Clinical & Real-World Evidence Generation Support IIS (Investigator Initiated Studies), PMS, and RWE projects. Coordinate with clinical teams for ongoing studies and data generation. Assist in publication planning and execution. Cross-Functional Collaboration Work closely with Marketing, Regulatory, Pharmacovigilance, Market Access, and Sales teams. Ensure medical and promotional compliance as per company SOPs and regulatory guidelines. Medical Information & Governance Review promotional materials from a medical and compliance perspective. Ensure timely and accurate responses to medical information queries. Maintain high ethical standards in all medical interactions. People Management Manage and support Medical Science Liaisons (MSLs) / Medical Advisors. Provide guidance, set objectives, and track performance. Contribute to team development and capability building. Qualification & ExperienceMD / MBBS, BDS or PharmD / PhD with relevant experience Experience 3–6 years of experience in Medical Affairs Exposure to Oncology therapy area preferred

Responsibilities Oversee machine operations, ensuring the adherence to Standard Operating Procedures (SOPs). Ensure product quality and compliance with SOPs, industry regulations, and customer specifications. To involved in the qualification (IQ/OQ/PQ) of equipments i.e vessels, Ball mill, Dyno mill, Leak testing machine, DPB, Filling machine dispensing booth. Conduct routine cleaning, checks on equipment maintenance and ensure adherence to safety protocols. Handle production documentation, including batch records, and ensure accurate recording as per AlCOA +.Qualification & ExperienceQualifications Qualification: Min Diploma or Graduate BSc Experience: 2 years plus

Responsibilities Manage all medical aspects of contracted pharmacovigilance tasks across the pharmaceutical product life cycle.  Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues, as well as client SOPs/directives, project-specific WPDs for assigned projects, and the organization’s corporate policies and SOPs/WPDs.  Provide medical consultation to team members and communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.  Provide therapeutic and protocol training on assigned studies, as requested.  Assist in writing (interpretation of safety data) and/or reviewing the safety portion of the CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules; scientifically review aggregate reports, contribute to label updates, review and assess literature, and support dossier maintenance and risk management activities to ensure that the medical content is accurate and complete.  Provide medical review of cases and perform reviews of adverse events of special interest and serious adverse events.  Perform data reviews as specified in the client contract and data validation manual, including review of coding listings and/or full safety data to assess potential safety concerns. Medically review adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted. Qualification & Experience MD or equivalent or MBBS (with 2 years of clinical experience) required. Active medical licensure preferred.

Responsibilities Medical Monitoring: Primarily serves as Global Medical Advisor on assigned projects. Serves as Scientific Advisor and provides guidance to Project Leaders on the medical and scientific aspects of assigned projects. Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility. Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs). Provides therapeutic area/indication training for the project clinical team. Attends and presents at Investigator Meetings. Performs review and clarification of trial-related Adverse Events (AEs). May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department. May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department. May perform medical review of adverse event coding. Performs review of the Clinical Study Report (CSR) and patient narratives. Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested. Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.  May require regular travel.  Extensive use of keyboard requiring repetitive motion of fingers.  Extensive use of telephone and face-to-face communication requiring accurate perception of speech.Qualification & ExperienceMedical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Minimum of 5 years' experience in clinical medicine, in addition to 4 years' clinical trials experience as an investigator or in the Pharma, CRO, or Biotech industry. Specialty Board certification required. Medical Oncologist (certification preferred)

Responsibilities Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary  Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements  Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data  Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported  Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable  Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product’s safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc)  Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective  Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment.  Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team  Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives  Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable  Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable  Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicableQualification & ExperienceOther A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education. Req  Three (3 years) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience. Req  Two (2) years of pharma experience Pref  Or equivalent combination of education, training, and experience in clinical practice, or pharma (practice, or pharmacovigilance, contract research associate etc) may be considered. Req  Sound knowledge of Medicine

Qualification & Experience MD / DNB in General Medicine  Freshers & Experienced candidates can apply