As a Sales Representative for the ophthalmology segment, your role involves promoting and selling the portfolio to Healthcare Providers (HCPs) in various settings such as institutions, hospitals, and private practitioners. Your primary focus will be on achieving monthly, quarterly, and annual sales targets within your assigned territory. It is essential to drive new business development by establishing a presence in new hospitals and identifying institutional Key Opinion Leaders (KOLs) through effective customer profiling. Building and maintaining strong relationships with targeted customers and stakeholders is crucial for success in this role. You will also be required to analyze business analytics to identify trends and develop strategies to stay competitive in the market. Additionally, promoting product differentiators to enhance brand recall among doctors is a key aspect of your responsibilities. Your additional responsibilities include updating the Must-See List (MSL) in the Customer Relationship Management (CRM) system regularly to ensure coverage of all key doctors. It is important to submit Daily Call Reports (DCR) to consistently log field activities. Maintaining an optimal primary vs. secondary sales ratio, meeting or exceeding budgeted sales revenue and collections, and prioritizing time and resources towards high Return on Investment (ROI) customer engagements are also part of your role. Overall, your role as a Sales Representative in the ophthalmology segment involves proactive sales strategies, relationship building, data analysis, and effective communication to achieve sales targets and drive business growth.,
As an Account Manager at our company, you will be responsible for managing key accounts in the healthcare industry. Your primary focus will be on building and maintaining strong relationships with hospitals, specialty clinics, and healthcare professionals. You will act as the main point of contact for any account-related queries, support, or issue resolution. Key Responsibilities: - Build and maintain strong, long-term relationships with key accounts in the healthcare industry. - Act as the single point of contact for account-related queries, support, and issue resolution. - Develop and implement account-specific strategies aligned with company goals. - Identify opportunities for growth, propose tailored solutions, and drive account penetration. - Achieve and exceed assigned sales targets and objectives. - Monitor account performance, analyze sales data, and recommend actions for improvement. - Conduct competitor benchmarking and market analysis to identify trends, risks, and opportunities. - Stay current on regulatory changes, therapeutic advancements, and evolving treatment pathways in CNS. - Partner with marketing, medical affairs, market access, and product development teams for effective execution of account strategies. - Prepare and deliver timely reports on account performance, customer feedback, and competitive insights to senior management. Qualifications Required: - Bachelor's degree in a related field (MBA preferred). - Proven experience in account management or sales in the healthcare industry. - Strong communication and negotiation skills. - Ability to work collaboratively in a cross-functional team environment. - Proficiency in data analysis and reporting. If additional details about the company are provided in the job description, please include them here.,
As an Engineering Compliance Specialist, your primary role will be to ensure all engineering activities are carried out in compliance with cGMP, GEP, and site SOPs. This includes handling quality documents such as Change Controls, Deviations, CAPA, and Quality Risk Management. You will review and update the planner to ensure activities are completed on time and prepare/revise SOPs for plant machinery, utilities, HVAC, and water systems. Additionally, you will support preventive maintenance execution, assist in equipment installation/commissioning, and ensure effective training through review and feedback. Your responsibilities as a Department Training Coordinator will involve updating training records, generating re-training requirements, preparing/reviewing training matrices, and managing training needs. You will also ensure new joiners are trained according to the function mapping and training plan, upload training materials, and track completion to maintain departmental training compliance. In Layout Preparation and Drawing Management, you will develop engineering layouts, floor plans, and technical drawings using AutoCAD. This includes collaborating with project engineers and utility teams to create accurate layouts, maintaining drawing storage/version control, and validating vendor-provided drawings for accuracy. You will also conduct site measurements, generate drawing revisions, and ensure audit readiness at all times. Your role will also involve supporting audit activities, participating in audits, and ensuring timely closure of audit observations. Additionally, you may be required to perform other duties as assigned by the Head of Department and contribute to continuous improvement initiatives within the department related to operations and documentation. This company emphasizes a culture of compliance, quality management, and continuous improvement within the engineering department.,
As a candidate for the position, your role overview will include the following responsibilities: - Responsible for maintaining self-hygiene. - Preparation, review, revision, control, and implementation of standard operating procedures in the sterile manufacturing department. - Preparation and review of master production documents. - Preparation and review of protocols and reports as required. - Handling document management including BMRs, BPRs, and master SOPs. - Managing change control, deviations, CAPA, investigations, etc. - Overseeing manufacturing, filling & sealing, labeling, and packing operations. - Creating monthly and daily production planning based on material availability. - Generating daily production reports. - Ensuring equipment and lines are validated and calibrated. - Adhering to cGMP, GDP, and maintaining discipline in the department. - Checking and maintaining records and log books related to manufacturing processes. - Providing training to subordinates, technicians, and operators. - Flexibility to perform additional activities as instructed by the HOD. In addition, your qualifications should include: - Filling, stoppering, and sealing: Beginner level - Equipment operation & cleaning (CIP/SIP): Proficient - Dispensing: Proficient - Sterilization & Depyrogenation: Proficient - Mixing: Beginner - Decartoning: Beginner - Washing: Beginner - Filtration: Proficient - Process Validation: Proficient - Troubleshooting (Problem Solving): Proficient - Packing process understanding: Beginner - People management & team leadership: Beginner Please note that the job description did not include any additional details about the company.,
As a Line Clearance Officer, your role involves ensuring proper line clearance activities before commencing various operations like dispensing, manufacturing, filling, inspection, sealing, labeling, and packing. You will be responsible for conducting process validation, cleaning validation/verification, hold time study, media fill, and routine batch sampling as per protocol/SOP. Additionally, you will review executed BMRs and BPRs and perform in-process tests at different stages as per batch document/SOP. Your key responsibilities will include: - Reviewing environment monitoring and water trends - Reviewing different types of planner and calibration certificates - Receiving necessary resources for EM monitoring from the microbiology lab and ensuring proper handover after completion - Monitoring cGMP compliance at the shop floor - Reviewing various printouts such as CIP, SIP, autoclave, filter integrity, etc. - Maintaining issuance/reconciliation records of items/media for Environment monitoring material - Conducting environmental monitoring of the manufacturing clean room area as per the defined schedule - Participating in media fill simulation study and qualification activities of the manufacturing area - Performing non-viable particle monitoring and compressed air/nitrogen gas monitoring - Reviewing Media fill CD and Visual inspector qualification record Skills required for this role include managing environmental conditions such as temperature, humidity, and light during stability testing to ensure accuracy and compliance with product degradation. No additional company details were provided in the job description.,
As a Manufacturing Area Operator, your role involves attending training sessions as per schedule and ensuring that work is aligned with the Training Needs Identification (TNI). You will be responsible for monitoring and performing all activities within the Manufacturing area, including filling logs, Batch Manufacturing Records (BMRs), and other documents in accordance with Standard Operating Procedures (SOPs). Additionally, you will need to adhere to the preventive maintenance schedule for machines, instruments, and equipment in the manufacturing area, as well as oversee cleaning and sanitization processes. Key Responsibilities: - Attend training sessions as per schedule and align work with Training Needs Identification (TNI). - Monitor and perform all activities within the Manufacturing area. - Fill logs, Batch Manufacturing Records (BMRs), and documents in the area following SOPs. - Follow the preventive maintenance schedule for machines, instruments, and equipment. - Ensure cleaning and sanitization of machines, instruments, equipment, and the manufacturing area. - Conduct line clearance activities before operations, Clean-In-Place (CIP), and Steam-In-Place (SIP) of Vessel. - Operate machines such as Manufacturing Vessel and CIP module. - Report any observations or disturbances in the aseptic area to the supervisor immediately. - Maintain self-hygiene, cleaning, and sanitization standards in the area. - Update and maintain documentation as per SOPs. - Ensure the Unidirectional Airflow (UAF) is functioning properly. - Adhere to current Good Manufacturing Practice (cGMP), Good Documentation Practice, and discipline within the department. Qualifications Required: - High school diploma or equivalent. - Previous experience in a manufacturing or pharmaceutical environment preferred. - Strong attention to detail and adherence to SOPs. - Ability to work effectively in a team environment. - Knowledge of cGMP and other relevant regulations is a plus.,
As a candidate for this role, you will be responsible for attending training sessions as per schedule and ensuring that your work aligns with the Training Needs Identification (TNI). You will also be tasked with monitoring activities in both general and controlled areas, as well as the aseptic area. Your duties will include filling logs, Batch Manufacturing Records (BMRs), and other documents in the area according to Standard Operating Procedures (SOPs) and work execution guidelines. Additionally, you will be in charge of cleaning and sanitizing the area as per the established SOPs and following the preventive maintenance schedule for machines, instruments, and equipment in the area. Key Responsibilities: - Perform and monitor activities in general and controlled areas, as well as the aseptic area - Fill logs, BMRs, and other documents in the area according to SOPs - Clean and sanitize the area as per SOP - Follow preventive maintenance schedule for machines, instruments, and equipment - Conduct line clearance activities before commencing operations - Operate machines, instruments, and equipment in the area - Inform the supervisor immediately of any observations or disturbances in the aseptic area - Update self-hygiene practices, cleaning and sanitization procedures, and follow SOPs in the area - Ensure the Unit Area Filter (UAF) is working in the area - Follow cGMP, Good Documentation Practice, and departmental discipline - Perform all activities related to general and controlled areas - Follow the preventive maintenance schedule for machines - Clean and sanitize general and controlled areas as per SOP - Work according to the standard operating procedures of the sterile manufacturing department, including Filling and Sealing, Garment Washing, Equipment Washing, and Autoclave operations Qualifications Required: - Ability to perform CIP/SIP and manual cleaning as per SOPs - Proficiency in basic maintenance and lubrication tasks - Understanding of equipment validation and calibration processes Please note that the job description provided does not include any additional details about the company.,
As a Machine Operator, your responsibilities will include: - Following the preventive maintenance schedule of the machine. - Checking the Uninterrupted Air Flow (UAF) working in the area. - Informing the concern supervisor immediately about any observations or disturbances related to documents and machines in the area. - Filling the logs, Batch Manufacturing Records (BMRs), and documents of the area as per Standard Operating Procedures (SOP) and work execution. - Operating the machines and vessels of the area as per SOP. - Cleaning and sanitizing the area as per SOP. - Performing line clearance activity before commencing operations as per SOP. Your key responsibilities will involve: - Manufacturing, Filling, Packing, and Visual Inspection. Required Skills: - Performing cleaning and line clearance per SOP after batch completion. - Preventing cross-contamination through proper hygiene and documentation. - Verifying area readiness before starting a new batch.,
As a potential candidate, your role will involve: - Attending training sessions as per schedule and ensuring the training and work align with the Training Needs Identification (TNI). - Performing and monitoring all activities related to the Aseptic area. - Following the preventive maintenance schedule of machines, instruments, and equipment in the area. - Ensuring the cleaning and sanitization of machines, instruments, equipment, and the area. - Conducting line clearance activities before commencing operations, Cleaning In Place (CIP) and Sterilization In Place (SIP) of Filtration Vessel. - Operating machines such as Vial Filling Machine and Vial Capping Machine. - Reporting any observations or disturbances in the aseptic area to the supervisor promptly. - Staying updated on self-hygiene practices, area cleaning, and sanitization, following Standard Operating Procedures (SOPs), documenting activities in the area. - Recording area logs as per SOPs and executing work accordingly. - Ensuring the Unidirectional Air Flow (UAF) system is operational in the area. - Adhering to current Good Manufacturing Practices (cGMP), Good Documentation Practices, and maintaining discipline in the department.,
As a Supervisor in the Sterile manufacturing department, your role involves the preparation, review, revision, control, and implementation of standard operating procedures activities. You will also be responsible for overseeing Change control and CAPA processes. Your key responsibilities include: - Preparation, review, revision, control, and implementation of standard operating procedures activities - Oversight of Change control and CAPA processes - Document preparation such as CCF, SOP, Investigation, Risk Assessment, Protocol, etc. To excel in this role, you should possess the following qualifications and skills: - Quality Management Systems: Mastery level - CAPA (Corrective and Preventive Actions): Mastery level - Regulatory Compliance: Expert level - Change Control Management: Expert level - Report Writing: Expert level - Audit & Inspection Readiness (Internal & External Audits): Expert level - Capability Development: Expert level - Manufacturing Process and Equipment Understanding: Expert level - Communication & Collaboration: Expert level If there are any additional details about the company in the job description, kindly provide them for further insights.,
You will be responsible for leading and implementing OpEx initiatives such as Lean, Six Sigma, and Kaizen. Your role will involve identifying, designing, and implementing process improvement projects across various functions. It will be crucial to ensure that all improvement initiatives adhere to GMP, safety, and regulatory requirements. You will also drive process improvements and cost-saving projects, monitor and enhance operational KPIs, and collaborate with cross-functional teams for sustainable improvements. Additionally, you will support digital transformation and automation initiatives, and develop and implement training programmes to build a culture of continuous improvement. Qualifications Required: - Proven experience in leading and implementing OpEx initiatives. - Strong knowledge of Lean, Six Sigma, and Kaizen methodologies. - Excellent understanding of GMP, safety, and regulatory requirements. - Ability to drive process improvements and cost-saving projects. - Experience in monitoring and enhancing operational KPIs. - Strong collaboration skills with the ability to work with cross-functional teams. - Familiarity with digital transformation and automation initiatives. - Experience in developing and implementing training programmes for continuous improvement.,
As a candidate, you will be responsible for the following tasks: - Updating on self-hygiene. - Preparing, reviewing, revising, controlling, and implementing standard operating procedures of the sterile manufacturing department. - Preparing and reviewing Protocols and reports based on the requirements. - Managing Document management like BMRs, BPRs, Master SOPs etc. - Handling Change Control, Deviations, CAPA, Investigation, etc. - Generating general purchase indent for departmental general items. - Preparing production planning on a monthly and daily basis as per the requirement and availability of materials. - Creating daily production reports based on the production achieved. - Ensuring that all equipment and lines are in a validated and calibrated status. - Following cGMP, GDP, and discipline in the department, and ensuring all employees comply with the same. - Providing training to all subordinates, technicians, and operators of the department. - Performing activities beyond the defined job responsibilities as per the requirement of HOD, following HOD's instructions and guidance. - Attending training as per the training schedule and ensuring training as per TNI. - Preparing and reviewing all-master documents of production. - Ensuring cleaning, sanitization, and operation of machines as per Standard Operating Procedures. - Controlling aseptic area operations like sterilization, manufacturing, washing & dehydrogenation, filling and sealing, etc. - Conducting line clearance activity before commencing operations like manufacturing, filling & sealing. Skills required for this role include: - Compliance with Good Manufacturing Practices (GMP) and regulatory standards (USFDA, MHRA, WHO, etc.). - Completion of Batch Packing Records (BPRs), logbooks, and deviation reports. - Maintaining traceability and strictly following SOPs.,
As an API Production Operator, your role involves operating and monitoring equipment used in various stages of API production. You will be responsible for ensuring the cleanliness and readiness of equipment before batch charging, maintaining accurate records, and executing batch operations strictly as per SOPs and GMP guidelines. Your key responsibilities include: - Operating and monitoring equipment such as reactors, centrifuges, dryers, millers, and sifters. - Ensuring cleanliness and readiness of equipment before batch charging. - Maintaining accurate records including Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), and Batch Packing Record (BPR). - Monitoring and recording process parameters in real-time to ensure adherence to specifications and quality. - Reporting and coordinating with Engineering for any equipment breakdowns. - Handling raw materials, intermediates, and APIs ensuring proper storage and documentation. - Following standard procedures for sampling and in-process testing of materials. - Monitoring utilities in the plant and reporting abnormalities. - Performing daily verification and calibration checks of weighing balances. - Participating in periodic equipment cleaning and preventive maintenance. - Identifying process deviations, malfunctions, or quality concerns and reporting them immediately. - Supporting continual improvement by suggesting ideas for optimization and waste reduction. - Adhering strictly to safety practices and participating in emergency response activities. In addition to the above responsibilities, you will also be involved in: - Supporting process improvement initiatives and lean manufacturing practices. - Assisting in the qualification and validation of equipment and processes. - Ensuring readiness of the area for audits and investigations. - Participating in cross-functional meetings and maintaining discipline and GMP compliance. - Training and mentoring junior staff/operators on standard procedures and safe working practices. - Supporting the preparation and review of SOPs related to manufacturing activities. - Participating in safety drills, risk assessments, and incident investigations. - Coordinating with stores for timely availability of materials and reporting daily production updates. Your skills in API Manufacturing Operations, Batch Documentation, GMP Compliance, Process Monitoring, SOP Adherence, Safety, Material Handling, Team Coordination, and Communication will be essential for this role. Your proficiency levels range from Basic to Advanced in these areas.,
As a QC Supervisor, your role involves planning and supervising preventive maintenance, calibration, and verification of QC instruments. You are responsible for ensuring the timely release of raw materials, intermediates, and packing materials according to approved specifications. It is essential for you to maintain strict compliance with GLP, safety protocols, and laboratory housekeeping standards. Your key responsibilities include: - Preparing and reviewing stability protocols - Monitoring sample charging/withdrawal and approving stability reports - Investigating deviations, OOS, OOAL, and incidents, and implementing effective CAPA - Reviewing and approving QC-related change controls, SOPs, and specifications - Conducting audit trail reviews and ensuring electronic data integrity for software-enabled instruments - Overseeing LIMS operations and ensuring accurate documentation and traceability - Identifying training needs and supporting skill development for QC personnel - Managing analytical column inventory and laboratory standards in accordance with SOPs In addition to the essential functions, you will be expected to: - Support internal/external audits and regulatory inspections - Drive continual improvement initiatives in QC processes and compliance - Perform any additional assignments allocated by QC Head/Designee Skills required for this role include: - Advanced knowledge of GLP & GDP Compliance, Stability Study Management, Data Integrity & LIMS Operations, Deviation/OOS Investigation, Regulatory Compliance & Documentation, and Leadership & People Development Other skills that would be beneficial: - Laboratory Data Management - Stability Study Documentation - Specifications & Test Methods Documentation - Analytical Method Validation Documentation - CAPA, Deviation, and Change Control Management - Training and Compliance Record Management - Knowledge of Regulatory guidelines/Requirement - Analytical evaluation of vendor - Method Validation/verification Protocol Design/review - GMP Compliance for Environmental Monitoring - Documentation & Data Integrity Practitioner While the job description does not provide additional details about the company, your role as a QC Supervisor will be crucial in ensuring the quality and compliance of the company's products.,
As a Sales Account Manager at this company, your role will involve managing and nurturing relationships with top key hospital accounts to drive sustainable growth and value selling. You will be responsible for achieving monthly, quarterly, and annual sales targets in the assigned territory. Your responsibilities will include: - Driving and expanding business within identified key accounts by monitoring competitor activity, anticipating barriers, and ensuring product access. - Engaging, developing, and maintaining relationships with Key Opinion Leaders (KOLs) and Key Business Leaders (KBLs). - Driving new conversions in large corporate accounts, developing a sales pipeline, and conversion plan. - Conducting regular reviews of key account performance and taking corrective actions to meet targets. - Building and maintaining accurate sales forecasts (state-wise) to align with budget goals. - Identifying and managing relationships with internal and external stakeholders across key accounts. - Ensuring customer satisfaction through surveys, addressing concerns, and updating uncovered doctors in CRM (Must-See List). - Promoting the company's brand differentiators to enhance recall among doctors. - Building deep relationships with decision-makers and influencers in key accounts, adhering strictly to compliance guidelines. - Executing account strategies with measurable KPIs to ensure effectiveness and efficiency. - Providing channel performance reporting and execution analytics to support management reviews. In addition to the above responsibilities, you will also have the following additional responsibilities: - Supporting business development initiatives to enter new hospitals and expand account coverage. - Collaborating with the Commercial Excellence team to design performance dashboards. - Maintaining sales reporting accuracy using Salesforce or other automation tools. - Participating in strategic planning and contributing to market insights for product positioning. - Adapting to changing priorities and competitive environments with agility and a problem-solving mindset.,
Role Overview: You will be responsible for operating the machines, cleaning and sanitizing the visual inspection and packing area, and performing all packing related activities. Additionally, you will need to fill the log of the general area as per SOP, attend training sessions as per schedule, and ensure the training aligns with TNI requirements. Following the preventive maintenance schedule of the machine, informing supervisors of any observations or disturbances, and adhering to cGMP, Good Document Practice, and departmental discipline are also key aspects of this role. Line clearance activities before commencing operations will also be part of your responsibilities. Key Responsibilities: - Operate the machines - Clean and sanitize the visual inspection and packing area - Perform all packing related activities - Fill the log of the general area as per SOP - Attend training sessions as per schedule and ensure alignment with TNI - Follow the preventive maintenance schedule of the machine - Inform supervisors of any observations or disturbances - Adhere to cGMP, Good Document Practice, and departmental discipline - Conduct line clearance activities before commencing operations Qualifications Required: - Previous experience operating machines in a manufacturing environment - Knowledge of cGMP and Good Document Practice - Strong attention to detail and ability to follow SOPs - Effective communication skills to report observations to supervisors (Note: Additional details about the company were not provided in the job description.),
As a Warehouse Executive, your role involves maintaining and following SOP procedures in day-to-day warehouse activities. This includes tasks such as receipt of materials, physical verification, and preparation of Good Receipt Note in ERP systems. You are responsible for affixing status labels (Quarantine) on all received materials and ensuring movement as per status updating. It is essential to update records according to cGMP standards for activities like cleaning, balance verification, and maintaining logs. Your role also requires coordination with production, QCC, QA, and Maintenance departments to ensure smooth functioning of relevant activities. Proper storage of materials based on their storage conditions is crucial. You will be responsible for transferring approved Raw materials and Packaging material from the Quarantine area to the release area after receiving approved GRN from QC. In addition, you will monitor material retest dates, handle material transfers, and issue material as per BMR/BPR and Material Requisition slip. Deducting issued material from software and maintaining stock records accurately is part of your responsibilities. Regular physical stock verification as per schedule is necessary. You will be involved in project work related to warehouse execution and reviewing QMS-related documents such as CCF, Deviation, and CAPA. Monitoring overall ERP functions and generating reports as required are also part of your duties. Ensuring that all Finished Good Receipts (Transfer) adhere to SOP norms for safe material handling, storage, and documentation is crucial. Skills required for this role include accurate recording in stock registers, bin cards, and warehouse management systems (WMS). You will also be responsible for completing material issuance records, receipt logs, and dispensing logs. Compliance with Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP) is essential. Qualifications Required: - Relevant experience in warehouse management - Familiarity with ERP systems and warehouse procedures - Knowledge of cGMP standards and quality management systems - Strong communication and coordination skills - Ability to work effectively with cross-functional teams Company Details: (if available) - The company emphasizes the importance of maintaining high-quality standards in warehouse operations and ensuring compliance with regulatory requirements. - Opportunities for professional growth and development within the organization are provided to employees who demonstrate dedication and performance excellence.,
As a Packing Department Officer, your role involves the following key responsibilities: - Preparation, review, revision, control, and implementation of standard operating procedures for the packing department. - Preparation and review of master documents related to packing. - Preparation and review of protocols and reports as per requirements. - Management and preparation of documents such as BPRs, master SOPs, etc. - Identification of training needs and provision of SOPs and developmental training within the department. - Handling of Change Control, Deviations, CAPA, Investigations, and other related tasks. - Assisting the packing officer in line clearance activities before operations like labeling and packing. - Ensuring timely requisition of materials needed for the next day's production plan. - Monitoring all packing-related activities. - Preparation of monthly and daily production planning based on material availability. - Compilation of daily production reports reflecting the achieved production. - Support for validation, calibration, and verification processes. - Checking and maintenance of all records and logbooks in the packing area. - Upkeeping the area with all required documents and ensuring cleanliness. Additionally, if there are any further details about the company in the job description, please provide them for a comprehensive understanding.,
As a candidate for this position, you should have knowledge of handling instruments of HPLC, performing analysis on various instruments, troubleshooting, expertise in LIMS, and awareness about data integrity. Additionally, having good communication skills is essential. Your key responsibilities in this role will include: - Demonstrating knowledge of guidelines and updating in pharmacopeia - Being ready to take on new responsibilities - Following current GLP and guidelines diligently No additional details about the company are provided in the job description.,
As a Document Management Specialist, your role involves handling various responsibilities related to document management, production processes, and quality compliance. Your key responsibilities include: - Managing documents such as BMRs, BPRs, and master SOPs to ensure accuracy and completeness. - Preparing and reviewing master production documents to maintain quality standards. - Ensuring the proper functioning of the UAF in your designated area. - Handling change control, deviations, investigations, and CAPA processes efficiently. - Providing training to subordinates, technicians, and operators to enhance their skills and knowledge. - Conducting line clearance activities before starting production operations. - Checking and maintaining records and logbooks related to aseptic manufacturing processes. - Developing, reviewing, and implementing standard operating procedures for the sterile manufacturing department. - Overseeing cleaning and sanitization activities in General, Controlled, and Aseptic areas. - Promptly reporting any observations or issues with documents or machines to the department head. - Monitoring activities in General, Control, and Aseptic areas to ensure compliance with standards. - Verifying the qualification and calibration status of equipment and instruments to prevent delays. - Ensuring timely completion of scheduled activities in designated areas. - Participating in training sessions as per the schedule and adhering to the training needs identified. - Upholding cGMP, Good Document Practice, and discipline within the company premises. In addition to your responsibilities, your skills should include expertise in filling, stoppering, sealing, and decartoning, as well as proficiency in equipment operation, cleaning, dispensing, sterilization, mixing, washing, and batch documentation review. You should also have a basic understanding of cleaning, line clearance, people management, and team leadership. This role requires meticulous attention to detail, strong communication skills, and a commitment to upholding quality and compliance standards in document management and production processes.,