37 Production Documentation Jobs

The role of Production Documentation at Ryzer Pharmaceutical Pvt Ltd involves preparing, reviewing, and maintaining various production documents such as batch records, SOPs, and technical documents. It requires ensuring compliance with cGMP standards, regulatory requirements, and company policies. Collaboration with cross-functional teams including production, quality assurance, and regulatory affairs is essential. Developing and implementing document control processes to ensure accuracy, completeness, and timeliness is a key responsibility. Regular audits are conducted to ensure document compliance and identify areas for improvement. Providing training and support to production staff on documentation procedures is also part of the role. Maintaining accurate and up-to-date records of production documentation and participating in continuous improvement initiatives to enhance documentation processes are crucial aspects of the job. The ideal candidate for this position should have 1-3 years of experience in production documentation or a related field in the pharmaceutical industry. A Bachelor's degree in Pharmacy, Chemistry, or a related field is required. Strong knowledge of cGMP, regulatory requirements, and document control processes is essential. Excellent communication, interpersonal, and problem-solving skills are necessary. The ability to work in a fast-paced environment, prioritize multiple tasks, and adapt to change is vital. Ryzer Pharmaceutical Pvt Ltd offers a competitive salary and benefits package along with the opportunity to work with a leading pharmaceutical company. The work environment is described as collaborative and dynamic, providing professional development and growth opportunities. Interested and detail-oriented individuals with a passion for production documentation can apply by sharing their CV via email at hrd_adm@ryzerpharma.com or by contacting the company at 7984001005. Walk-in interviews are being conducted for this position, and only shortlisted candidates will be contacted for further interviews.,

We are looking for a meticulous Chemist Production to manage production documentation preparation and batch record review at Synnat Pharma Private Limited. As a key member of our API Manufacturing Unit, you will play a crucial role in ensuring seamless production processes and adherence to the highest quality standards. Your responsibilities will include verifying daily logbooks, reviewing online Batch Manufacturing Records, and managing all production-related documents, including Process Deviation Control Orders (PDCOs). You will also be responsible for raw material indenting, updating activities in our ERP system, and participating in preventive maintenance programs. This role requires close coordination with the Shift In-charge and other departments to effectively follow production plans and maintain cGMP compliance. You will contribute to both internal and external audits, ensuring our operations meet regulatory requirements. Your expertise will be vital in maintaining the integrity of our manufacturing processes and supporting our commitment to quality and efficiency. If you are passionate about pharmaceutical production and thrive in a collaborative environment, we encourage you to apply. Responsibilities: 1. Create and prepare documentation for production operations with proficiency in MS Word and Excel. 2. Conduct thorough batch record reviews (BMRs, PDCOs, cleaning records) to ensure accuracy, completeness, and compliance with cGMP. 3. Prepare, update, and maintain production-related documents and SOPs, ensuring traceability and audit readiness. 4. Collaborate with QA to resolve discrepancies or deviations and implement corrective actions. 5. Coordinate with the Shift In-charge to execute production plans and meet timelines. 6. Indent raw materials, track consumption, and maintain accurate ERP entries for production activities. 7. Monitor inventory levels, report shortages, and support dispatch documentation after batch completion. 8. Support internal and external audits by providing required records and ensuring compliance with regulatory standards. 9. Investigate process deviations, prepare reports, and assist in implementing CAPA. 10. Participate in preventive maintenance scheduling and maintain equipment calibration/maintenance records. 11. Coordinate with maintenance teams to address equipment malfunctions and ensure readiness. 12. Conduct self-inspections of production areas to identify compliance gaps and propose improvements. 13. Ensure safety, adherence to cGMP practices, and continuous improvement in production operations. General Expectations and Past Experiences: Experience in API manufacturing with focus on batch record review and documentation preperation accuracy. Strong understanding of cGMP, PDCOs, and production documentation practices. Proficiency in ERP production modules for material management and tracking. Familiarity with preventive maintenance coordination and equipment validation. Experience in supporting audits and implementing CAPA. Strong analytical skills, attention to detail, and cross-functional collaboration.

We are looking for a meticulous Asst. Manager Production to lead production activities at Synnat Pharma Private Limited, ensuring seamless API manufacturing operations and adherence to the highest quality standards. As Asst. Manager Production, you will play a pivotal role in overseeing daily production activities, monitoring validation batches, and ensuring compliance with cGMP guidelines. Your responsibilities will include the preparation and review of production-related documents, coordination with cross-functional teams, and active participation in internal and external audits. You will also be responsible for identifying and resolving operational gaps, managing deviations and Out-of-Specification (OOS) incidents, and implementing Corrective and Preventive Actions (CAPA). With a strong focus on process optimization and continuous improvement, you will contribute to enhancing production efficiency and maintaining a facility that is always audit-ready. Your expertise in QMS (Quality Management Systems) and experience with ERP systems (SAP) will be crucial in driving operational excellence and ensuring the delivery of high-quality pharmaceutical products. Responsibilities: Oversee daily API production activities, ensuring compliance with established procedures and cGMP guidelines. Monitor validation batches, process parameters, and Batch Manufacturing Records (BMR/MBMR) for accuracy. Verify online BMRs and ensure compliance with regulatory and documentation standards. Coordinate with utility, QC, Stores, and Engineering teams to support seamless production operations. Supervise movement of finished products, intermediates, and recover solvents as per protocols. Identify and resolve operational gaps at the floor level to improve efficiency. Manage deviations, Out-of-Specification (OOS) incidents, and implement CAPA measures effectively. Ensure compliance with QMS and audit requirements; participate in internal and external audits. Prepare, review, and maintain accurate production documents, including validation protocols and training records. Develop preventive maintenance schedules, monthly production plans, and calculate raw material requirements. Train and mentor team members on production processes, compliance, and quality standards. Report production activities, deviations, and audit compliance to management while driving process improvements. General Expectations and Past Experiences: Strong understanding of API Manufacturing processes and cGMP guidelines. Demonstrated experience in preparing and reviewing production-related documents, including BMRs, validation protocols, and SOPs. Proven ability to manage and resolve deviations and Out-of-Specification (OOS) incidents effectively. Proficiency in using ERP Systems (SAP) for production planning, inventory management, and data analysis. Experience in participating in and contributing to successful internal and external audits. Strong leadership and communication skills with the ability to train and mentor production staff. In-depth knowledge of Cleaning Validation procedures and QMS (Quality Management Systems).

Hello, We are hiring for Operations Planner/Production Planning for- VASAI EAST location for our client manufacturing company. Looking for below experience- Monitoring daily operation planning Inventory management ERP (Oracle /SAP) Production planning exp Role & responsibilities To support efficient and timely production by handling daily planning, machine scheduling, system transactions (ORACLE), and maintaining accurate production data. The role ensures smooth coordination between planning and execution on the shop floor to meet customer demands and production targets Daily Production Planning: Assist in preparing daily/weekly production plans based on customer requirements and material availability. Monitor and update production schedules to ensure alignment with actual output and customer priorities. Machine Scheduling: Allocate jobs to machines based on capacity, priority, and machine availability. Coordinate with maintenance and production teams to minimize downtime and schedule adjustments. System Transactions: Perform accurate and timely system entries (e.g., production orders, material movements, consumption, GRN). Ensure the system reflects real-time production status for traceability and reporting. Data Management & Reporting: Maintain daily production data (output, downtime, scrap, etc.) and generate regular reports for review. Support monthly and weekly MIS preparation. Ensure production documents and records are properly maintained as per audit and quality requirements. Coordination & Communication: Liaise with store, QA, maintenance, and other internal departments to ensure smooth production flow. Escalate delays, material shortages, or system issues to supervisors for timely resolution. Continuous Improvement: Suggest improvements in planning, documentation, and system accuracy to increase efficiency and reduce losses. 3-5 years of hands-on experience in Production Planning & Control in a moulding shop or similar discrete manufacturing setup. Experience in cell manufacturing is important the planner should understand cell-level load balancing , material staging , and sequencing . Looking for candidates who can join immediately or within 1 week.

The opportunity As a part of Hitachi Energy, a global technology leader with operations in approximately 100 countries and a team of 40,000 experts dedicated to advancing a sustainable energy future for all, you have the chance to be a key contributor in our HVDC & FACTS factory located in Chennai, Tamil Nadu, India. The factory, strategically situated near the port and airport, specializes in the assembly and testing of three different converter valve technologies - LCC, VSC, and STATCOM (FACTS). At this cutting-edge facility, you will play an essential role in the control and protection testing for FACTS applications, all within a state-of-the-art environment that prioritizes quality and innovation. How you'll make an impact - Adhere to Health, Safety & Environment (HSE) standards and business compliance regulations within the units. - Take responsibility for the respective Assembly Station and associated Production tools, focusing on the assembling of HVDC Valve Converters. - Generate production documentation including assembly/work instructions and reports, contributing to meeting production KPI targets such as FPY, On-time, and On-cost delivery. - Drive the development of best practices to enhance production capacity, quality, and reliability. Analyze workflow, space requirements, equipment layout, and implement lean manufacturing principles to minimize downtime. - Conduct studies on assembly tools, fixtures, and ergonomics. Maintain Shopfloor 5S standards to ensure efficient operations. - Ensure compliance with relevant external and internal regulations, procedures, and guidelines while upholding Hitachi Energy's core values of safety and integrity. Your background - Hold a Diploma in Mechanical, Electrical & Electronics, Electronics & Communication, or Instrumentation Engineering. - Proficiency in both spoken and written English language is essential for effective communication and collaboration. If you are a qualified individual with a disability and require reasonable accommodations to access the Hitachi Energy career site or support during the job application process, please complete a general inquiry form on our website. We are committed to providing accessibility assistance to job seekers with disabilities and ensuring a smooth application process tailored to your needs.,

We are hiring Executive - Production with 2-4 years' experience in API Pharma - Production for our manufacturing unit in Tumkur. Interested candidates with relevant experience can apply. Job Description 1. Managing day-to-day production operations while ensuring optimal utilization of materials, equipment, and personnel. 2. Ensuring full compliance with Good Manufacturing Practices (GMP), ICH guidelines, and applicable regulatory requirements including those set by the FDA and EMA. 3. Maintaining accurate and complete documentation of all production activities, including batch records, deviations, and related reports. 4. Driving continuous improvement initiatives by applying Lean Manufacturing and Six Sigma methodologies. 5. Actively participating in new product introductions and technology transfer activities to support seamless integration into production processes.

Ensure compliance with GMP & regulatory standards, oversee quality systems, audits & validations, manage QA team, review batch records, handle deviations/CAPA, support regulatory inspections, ensure product quality & safety across manufacturing.

The ideal candidate for this position should have a solid understanding of Injection molding processing and be capable of identifying process needs for new product development. You will be responsible for efficiently outlining all production processes with minimal wastage within specified timeframes. It will be crucial to uphold product quality and cycle time by consistently monitoring and controlling temperature, pressure, and speed in accordance with the raw material used. Your role will also involve troubleshooting quality and processing issues to minimize errors and ensure corrections are made promptly. Adherence to a daily maintenance and cleaning schedule for machines and auxiliary equipment is essential to uphold operational efficiency. You must possess the ability to accurately measure machine performance, scrap, waste, and downtime to maintain optimal production standards. Additionally, you will be expected to create and adhere to production documentation, including assembly instructions and process data. Generating reports on downtime and identifying potential trends will be part of your routine tasks. Assisting in mold changeovers and focusing on reducing SMED time are crucial aspects of this role. Maintaining a 5S environment in the plant and ensuring cleanliness is essential for workplace safety and efficiency. Flexibility to work in various shifts and departments is required. Moreover, your contribution to continuous improvement activities will be highly valued. This is a full-time position with benefits such as cell phone reimbursement, performance bonuses, and a day shift schedule. The work location is on-site.,

As a Shift In-charge for Injection Molding Production, you will be responsible for independently managing the shift. With 3-5 years of experience in Injection Molding, you will possess the necessary skills to handle mold loading/unloading, set processes with standard parameters, and provide training and facilitation to workers. A background in production documentation with knowledge of IATF standards is essential for this role. To qualify for this position, you should hold a Diploma in Engineering or CIPET. The salary range for this role is between 25K to 35K, and the location of work is in Devanahalli. This is a full-time job opportunity that requires your presence in person at the work location. In addition to a competitive salary, benefits such as Provident Fund will be provided. The ideal candidate will have a total of 4 years of work experience in a similar role. If you meet the qualifications and are ready to take on this challenging role, we look forward to receiving your application.,

We are seeking a dynamic, confident, and creative Video Production Intern to join our team. If you are passionate about filmmaking, enjoy being on set, and can communicate effectively, we invite you to be a part of our team. As a Video Production Intern, you will assist in planning and executing video shoots for various purposes such as corporate, CSR, events, and more. You will be responsible for coordinating with crew members, vendors, and talent during productions, handling basic production documentation, and assisting with on-set tasks. Additionally, you will have the opportunity to attend networking events and client meetings when required. This role offers a chance to learn the end-to-end production process in a real working environment. The ideal candidate for this position is smart, bold, and confident with excellent communication skills. You should be comfortable working in a fast-paced, creative environment and be eager to learn while taking ownership of tasks. Flexibility is key as you will be expected to attend shoots and events, including some days on location. The location of this position is in Bengaluru, and the joining date is immediate. The stipend offered is 10,000/month, which is performance-based. The duration of the internship is 3 months, with a possibility of extension or a full-time opportunity based on performance. If you believe you possess the skills and energy to excel in the film & video production industry, we encourage you to apply by sending your CV and a short intro video to sebin@wilmarcs.com.,

We are Hiring: Product Designer - Craft Contemporization, Collectible Design Location: On-site, Hyderabad Type: Full-time ( This is a full-time, on-site role in Hyderabad. Remote or hybrid applications will not be considered) At Nolwa Studio, we design collectible objects rooted in traditional craft, material exploration, and thoughtful detail. Were looking for a Product Designer to join our team - someone who doesnt just sketch ideas, but actively prototypes, iterates, and refines designs through thoughtful feedback and collaboration. What you will do Design and develop original, in-house product collections and translate the founder&aposs vision into tangible pieces Support and evolve existing product lines with a focus on consistency and refinement Translate design concepts into precise, production-ready drawings and prototypes Work closely with artisans, engineers, and fabricators to bring ideas to life with integrity Ensure each product upholds the highest level of detailing, functionality, and finish Contribute to material research, prototyping, and iterative testing What we are looking for 3+ years of experience in product/furniture design A strong eye for form, proportion, graphic design and materiality Proven ability to create accurate technical drawings and production documentation Comfortable working hands-on with materials and vendors A deep respect for process, precision, and collaborative making Prior experience with luxury design studios or high-end product ranges is a strong plus Degree in Product Design or a related design field Our studio is a space where experimentation meets intention, and where every product is a result of extensive research, material exploration, craft, and design intervention. If this sounds like you, we would love to hear from you. To apply, please include the link to your design portfolio in your CV Show more Show less

As a Shift Charge for Injection Molding Production, you will be responsible for handling the shift independently with a focus on Injection Molding processes. With 3-5 years of relevant experience, you will possess knowledge of mold loading/unloading, process setting with standard parameters, and the ability to train and facilitate workers. Additionally, familiarity with production documentation and an IATF background will be advantageous in this role. To qualify for this position, you should hold a Diploma in Engineering or CIPET. The salary range for this position is between 20K to 30K, and the location of work is in Tumkur. This is a full-time job with benefits such as Provident Fund. The working schedule involves rotational shifts, and the ideal candidate should have a total of 5 years of work experience. The work location is in-person, and the role requires a proactive approach to managing injection molding production efficiently.,

Being a production executive having eight to ten years experience in ointment & cream production in the production department. A reputed ointment & cream company is required urgently in Vapi and surrounding area. Required Candidate profile Having expertising in production documentation & production procedure handling subordinates efficiently & effectively. Having experience of various audits. Knowledge of WHGMP

Role & responsibilities Job Purpose: To ensure smooth and efficient operations of the AAC block production process in the assigned shift. Responsible for meeting production targets with optimal quality, safety, and resource utilization. Key Responsibilities: 1. Shift Operations: Plan and execute daily production activities as per the production schedule. Monitor the operation of key equipment such as slurry preparation, pouring, cutting, autoclaving, and Segregation. Ensure optimum utilization of manpower, machines, and materials during the shift. 2. Quality Monitoring: Ensure production of AAC blocks meets quality standards and BIS specifications. Coordinate with the Quality department to take immediate corrective actions on any quality deviations. Minimize rejections and wastage. 3. Manpower Management: Supervise and manage shift operators, technicians, and contract labour. Assign tasks, monitor performance, and ensure discipline and safety among the team. Provide basic training and support to the operators on SOPs and quality practices. 4. Coordination & Communication: Coordinate with Maintenance, Quality, and Utility departments for smooth plant operations. Handover proper shift reports to the incoming shift and report abnormalities to senior management. 5. Production Documentation: Maintain daily shift production logs, downtime records, material usage logs, and manpower deployment sheets. Ensure accurate ERP/Excel data entry for shift-wise production and performance tracking. 6. Safety & Compliance: Ensure strict adherence to plant safety guidelines and SOPs. Report and respond to near-miss incidents or accidents. Maintain cleanliness and follow 5S practices in the work area. 7. Continuous Improvement: Participate in improvement initiatives such as Kaizen, Lean Manufacturing, and TPM. Suggest and implement cost-saving and process improvement ideas. Key Skills Required: Thorough understanding of AAC block manufacturing process Strong leadership and team management capabilities Good problem-solving and decision-making skills Knowledge of BIS standards and production documentation Familiarity with ERP systems and MS Office Awareness of safety, quality, and productivity principles

The Production Supervisor position at Shree Jagdamba Hydropneumatics (JHydro) in Butibori, Nagpur, involves overseeing day-to-day production and assembly operations. As a Production Supervisor, your primary responsibilities will include supervising daily production activities on the shop floor, interpreting mechanical drawings and circuit diagrams, assigning technician tasks, coordinating with the store team for material issuance, ensuring quality control, maintaining production documentation, and collaborating with sales/service teams to align production with order requirements. To excel in this role, you must have a minimum of 2 years of experience in production or assembly supervision, a strong understanding of mechanical components and industrial hardware, the ability to read and interpret mechanical and pneumatic drawings, hands-on experience in pneumatics/hydraulics (preferred), proficiency in MS Excel and production documentation, as well as excellent leadership, communication, and time management skills. A Diploma or Bachelor's degree in Mechanical/Production Engineering or a related field is required. Proficiency in Hindi is a must, while basic English is preferred. The ideal candidate for the Production Supervisor position at Shree Jagdamba Hydropneumatics (JHydro) will be detail-oriented, proactive, and have a passion for ensuring quality and timely delivery of products. If you meet the qualifications and are ready to take on this challenging yet rewarding role, please send your resume to harshit123hap@gmail.com. Join us at Shree Jagdamba Hydropneumatics (JHydro) and be a part of a dynamic team that specializes in pneumatics, hydraulics, and automation systems, providing industrial solutions to OEMs and dealers with a focus on quality, reliability, and technical expertise.,

Being a production executive having eight to ten years experience in ointment & cream production in the production department. A reputed ointment & cream company is required urgently in Vapi and surrounding area. Required Candidate profile The responsibilities of an executive production in media production encompass a wide range of tasks, primarily focused on overseeing the entire project from inception to completion.

Handle BMR and batch repacking records, Verify daily balance checks and calibration activities, Maintain production records, Perform and verify line clearance at manufacturing and packing stages, Issue and retrieve production documents Required Candidate profile Graduate candidates with 2-4 Year experience and knowledge about cGMP Practice, QMS tools knowledge, Production and Manufacturing documentation process. We are looking for local candidates ONLY.

As a Production Manager in the Pharma industry, you will be responsible for overseeing the daily operations of a production team. Your primary goal will be to ensure that production schedules, quality standards, and safety regulations are consistently met to achieve organizational objectives. Your key responsibilities will include supervising and coordinating daily production activities to meet output, quality, and delivery targets. You will be expected to lead all production activities in compliance with Good Manufacturing Practices (GMP) and Current Good Manufacturing Practices (CGMP). Additionally, you will oversee the completion targets of intermediate and finished products, including the filling and completion of Batch Production and Control Records (BPCR) for submission to Quality Assurance (QA). In this role, you will be accountable for shift operations and activities, serving as the shift in charge. Monitoring critical process parameters during batch operations and processes, as well as ensuring the issuance of raw materials and maintaining consumption reconciliation, will be crucial aspects of your daily tasks. Furthermore, you will be responsible for various activities such as handling work permits, maintaining production shop floor logbooks, supervising vessel entry, ensuring area and line clearance, conducting preventive maintenance of equipment, and calibrating instruments. Your role will also involve utilizing Enterprise Resource Planning (ERP) systems for production, issuing labels for packaging materials, and coordinating with different departments to facilitate smooth production activities. Your role will also require you to plan production batches according to scheduled dispatch dates, maintain routine documents, ensure housekeeping and safety in the plant, and qualify equipment. You will be expected to submit monthly stock reports, prepare validation and optimization reports, and handle change controls, deviations, corrective and preventive actions (CAPA), and risk assessments. Additionally, you will be responsible for providing on-the-job and classroom training to workmen and supervisors on Standard Operating Procedures (SOP), new BPCR, CAPA, GMP, and CGMP, as well as reviewing, designing, implementing, and updating SOPs and BPCRs. Indenting for production items, performing hazard identification and risk assessments, and possessing proficiency in ERP systems, production documentation, communication, leadership, and problem-solving skills are essential for this role. Qualifications for this position include a B.E./B.Tech in Mechanical Engineering, at least 3-5 years of experience in a manufacturing/production environment, and prior supervisory experience. Industry-specific experience in Surgical and Pharma sectors is preferred. This is a full-time, permanent position that offers benefits such as health insurance, paid sick time, and Provident Fund. The work schedule includes day shifts, fixed shifts, and morning shifts, with performance and yearly bonuses provided. The work location is in Dewas, and the position is open exclusively to male candidates. If you are interested in this challenging role, please apply by sending your resume to HR.RISELEAD5@GMAIL.COM or contact us at 7068455582. We look forward to welcoming a dedicated and experienced Production Manager to our team.,

You are a skilled and detail-oriented CNC Operator who will be joining the growing team of an interior modular furniture manufacturing facility. Your main responsibility will be to operate HOMAG CNC machines to produce high-quality furniture and modular interior components. It is essential for you to have hands-on experience in operating HOMAG CNC machines and a strong understanding of woodworking processes, modular systems, and precision manufacturing standards. Your role will play a key part in ensuring the accurate and efficient production of modular furniture components and customized interior solutions. In this role, you will be responsible for setting up, programming, and operating CNC machines to produce furniture components. You will interpret technical drawings, CAD files, and production documentation to ensure accurate machining. Regular machine maintenance, cleaning, and calibration are also part of your responsibilities to maintain optimal performance. Monitoring machine operations, making adjustments as needed, and conducting quality checks on finished parts using measuring tools are crucial to confirm adherence to specifications. Collaborating with design, production, and assembly teams to optimize workflow and output is an important aspect of the job. Ensuring safe operation of machinery, adherence to health and safety protocols, troubleshooting technical issues, and coordinating with maintenance when necessary are also key responsibilities. Maintaining organized records of machine settings, part programs, and production logs is essential for the role. To be successful in this position, you must have proven experience operating HOMAG CNC machines in a modular furniture or wood-based manufacturing environment. A strong understanding of woodworking materials, ability to read and interpret technical drawings, and familiarity with CNC programming software are required. Attention to detail, commitment to quality and efficiency, basic knowledge of maintenance procedures for CNC machinery, and the ability to work independently and as part of a collaborative production team are also important qualities. Additionally, being physically fit and capable of handling materials and standing for extended periods is necessary. This is a full-time position with a day shift schedule. A diploma is preferred for education, and a minimum of 1 year of total work experience as a CNC operator is required.,

Production documentation, BPR review, Plant round, QC procedures knowledge and analytical raw review, QMS handling knowledge.

Roles and Responsibilities Mis Preperation Inventory reports, production reports. All to be prepared in excelDesired Candidate Profile Perks and Benefits

Role & responsibilities Planning and monitoring of manufacturing products/procedure Enforces company policies and guidelines Trains workers/helpers according to work Discuss to Implements cost-saving strategies and techniques. Ensures that production plans are completed by a certain time. Ensures that all manufacturing process run as per SOP Ensure that all plant activities documentation are properly prepared Contact to maintenance department for repair issues Guidelines workers/assistants on how to achieve an optimal output or workflow. Resolves routine issues regarding manufacturing. Creates and maintains batch schedules Communicate with and assists other manufacturing departments as needed. Evaluates the condition of production equipment and reporting to higher authority. Maintains a clean and safe environment for all workers. Compiles and analyses production records and product yield factor. Monitoring and ensure that there isno any unusual activities in plant premises by any person. Evaluation of material inputs vs output. Prepare daily and monthly production reports. Daily reporting to higher authority. Communicate with store person for procure input material. Communicate with quality person for regarding in-process control. All approvals or rejections shall be in consultation with the supervisor/reporting authority. Preferred candidate profile Training Impart training on Safety to new recruits, employees, contractors, contract employees. Periodically evaluate Training Effectiveness. Maintain updated records for all the Training activities Required behaviors and skills: Excellent problem-solving skills and attention to detail, strong communication skills. Candidate must have knowledge of computer i.e. MS Office, Email etc. Ability to work independently and as part of a team. Guiding and motivating the production team to achieve targets efficiently Taking responsibility for production outcomes and addressing any issues promptly. Being flexible and responsive to changes in production schedules or processes. Fostering a cooperative and supportive work environment. Understanding pharmaceutical production processes, equipment, and regulatory requirements. Identifying and resolving production issues quickly and effectively. Efficiently managing time and resources to meet production deadlines. Ensuring that all products meet quality standards and regulatory specifications. Knowledge of MS Office / Quality Reports Preparing production reports & documents Flexibility & Agility within the organization, working at different manufacturing sites within India.

Role & responsibilities Oversee and manage the entire manufacturing process. Handle Granulation, Compression , Coating and all other production related activities. Active calculation, dispensing of Raw Materials and batch reconciliation at various stages. In process checking at various intermediate stages of Granulation, Compression and Coating. Prepare IQ, OQ, & PQ of the process & utility equipment. Should handle process of validation batches Ensure online documentation of production activity on timely basis. Review of batch manufacturing record and other related documents for its completion of intermediate and final stage. Maintain the SOPs, Log books and other documents. BMR / BPR preparation in ERP and review.

• Strong knowledge of API manufacturing & GMP. • Proficient in batch documentation and SOPs. • Manpower handling.

We are seeking an experienced professional to lead Quality Assurance while supporting Regulatory Affairs activities at our API manufacturing facility. The ideal candidate will be responsible for ensuring overall compliance with QMS and regulatory standards, managing validations and audits, and maintaining product quality in line with international guidelines. Key Responsibilities: Lead The implementation and oversight of the site Quality Management System (QMS), including SOPs, validations, and document control. Conduct and manage internal and vendor audits; review deviations, non-conformances, and ensure timely CAPA execution. Review and approve Master Production Records, Batch Production Records, and Validation Protocols across departments. Coordinate process, cleaning, and analytical method validations as per the Validation Master Plan. Prepare, review, and manage regulatory documentation including DMFs/ASMFs in CTD format (Modules 1, 2, 3). Liaise with regulatory authorities and customers for audit readiness, document submissions, and compliance queries. Oversee training programs for plant personnel and ensure continuous adherence to GMP standards. Conduct Product Quality Reviews and implement risk management tools like FMEA, HACCP, and HAZOP where applicable. General Requirements: Thorough understanding of global regulatory guidelines (ICH, WHO, USFDA, etc.). Strong analytical, documentation, and decision-making skills. Proficient in regulatory submissions and quality review documentation. Familiarity with stability studies and establishing expiry/retest periods. Hands-on experience with validation protocols and equipment calibration systems. Ability to lead cross-functional teams and ensure site-wide compliance. Excellent verbal and written communication skills. Willingness to take ownership and drive continuous improvement initiatives.