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Aurore Life Sciences

Aurore Life Sciences specializes in providing innovative solutions and services in the field of biotechnology and pharmaceutical development.

23 Job openings at Aurore Life Sciences
Procurement Executive Hyderabad 0 - 3 years INR 2.0 - 4.0 Lacs P.A. Work from Office Full Time

Job Description: Position: Procurement Executive Department: Purchase Exp: 0 to 3 years Location: Corporate office, Hitech city Key Role and Responsibilities: • Source and procure raw materials as per production requirements. • Identify, evaluate, and select reliable suppliers based on quality, cost, and delivery timelines. • Negotiate contracts and terms with suppliers to ensure cost-effectiveness. • Monitor inventory levels and forecast material requirements. • Coordinate with production, warehouse, and quality departments to ensure timely material availability. • Maintain accurate records of purchases, pricing, and supplier performance. • Handle purchase orders, invoices, and follow-up on delivery schedules. • Assist in developing procurement strategies to support company growth and cost reduction. Requirements: Minimum 2 years of experience in raw material procurement Strong negotiation and communication skills Proficiency in excel and SAP Ability to handle multiple suppliers and maintain good vendor relationships. Problem-solving and decision-making abilities.

Business Development Executive Hyderabad 3 - 7 years INR 5.0 - 7.0 Lacs P.A. Work from Office Full Time

Job Description: Position: Business Development Executive(Domestic Market) Exp: min 3 Years Location: Hyderabad Key Role and Responsibilities: Conduct thorough market research to identify potential business opportunities, market trends, and competitor analysis. Analyse market dynamics and regulatory environment to identify key areas for business development initiatives. Develop and implement strategic business plans to expand the company's presence in the pharmaceutical sector. Identify and prioritize target markets, customer segments, and product opportunities based on market analysis. Identify and engage with potential clients, partners, and stakeholders through various channels such as networking events, conferences, and cold outreach. Build and maintain a robust pipeline of qualified leads and opportunities. Lead negotiations with potential partners, including licensing agreements, collaborations, and distribution agreements. Work closely with legal and finance teams to finalize terms and contracts. Cultivate and maintain strong relationships with key stakeholders, including pharmaceutical companies, regulatory bodies, research organizations, and healthcare professionals. Serve as the primary point of contact for existing and prospective clients, addressing their needs and ensuring high levels of customer satisfaction. Collaborate closely with internal teams including marketing, sales, product development, and regulatory affairs to ensure alignment and support for business development initiatives. Provide insights and feedback to support the development of new products and services tailored to market needs. Prepare regular reports and updates on business development activities, including pipeline status, progress against targets, and market insights. Analyse key performance indicators (KPIs) to assess the effectiveness of business development strategies and identify areas for improvement.

Assistant Manager Hyderabad 8 - 13 years INR 700.0 - 1000.0 Lacs P.A. Work from Office Full Time

In charge of creating the planning reports on a daily, weekly, and monthly basis. • Strategic planning, coordination, and execution to ensure efficient production schedules and timely delivery of high-quality pharmaceutical products • Updating and maintaining material master in ERP. •Developing and implementing production plans to meet business objectives ensuring optimal resource utilization and adherence to quality standards. •Managing and leading a team of production and planning professionals, fostering a collaborative and results driven work environment. •Creating and delivering reports on production performance on a regular basis, emphasizing successes and potential areas for development. •Keeping an eye on and controlling raw material and finished goods inventories. •Putting plans into action to reduce surplus inventories and steer clear of manufacturing. •Creating Purchase Requisitions in accordance with specifications to guarantee the timely delivery of API, packaging materials, and raw materials in compliance with production and packaging planning specifications. •Managing the CMO order book to determine the number of batches, create the monthly plan taking the shipping schedule and market priorities into account, and assign the batch numbers. •Working together with the purchase team and PM to ensure that the supplies needed for production are delivered on time and in accordance with the priorities. •Worked in tandem with the production team & CFT's to optimize lead times for manufacturing ,resulting in 10% increase in production output. •Negotiated advantageous prices, delivery dates, and terms of payment with manufacturers. •Found and assessed additional vendors, making careful pricing comparisons to guarantee economy of scale. •Oversaw every step of the procurement to receiving process for every manufacturer, guaranteeing accurate and timely fulfilment. •Carried out routine reviews of outstanding orders and started the required follow-ups to ensure timely and complete delivery of the materials

Deputy Manager Hyderabad 4 - 9 years INR 2.5 - 7.5 Lacs P.A. Work from Office Full Time

Role and Responsibility: Equipment mapping for Pre-validation / Validation batches. Prepare of Process Flow Diagram for pre-validation and validation batches. Execute the activities related to the Technology Transfer. Review the optimized process and provide suggestions for feasibility towards plant scale. Review the Lab/Kilo/Pilot data and understand the yield and quality trend. Active the same at plant batches considering the best as a benchmark. Preparation of volume calculation and Technology Transfer protocol for the product as per SOP. Preparation of Pre-validation batch report as per SOP and Technology Transfer report for validation batches as per SOP. Batch size determination, Utility calculation, Debottlenecking, Process optimization, Tro shooting. Handling change control initiation in Track wise & closing of scale up & validation batches.

Senior Research Chemist Hyderabad 3 - 5 years INR 3.0 - 5.0 Lacs P.A. Work from Office Full Time

Roles And Responsibility : Senior Research Chemist in the Process Research Department at Dr. Reddys Institute of Life Sciences, Hyderabad. Develop and execute laboratory experiments to successfully complete customer projects. Conducting feasibility studies, optimizing, and scaling up reactions for the synthesis of APIs, intermediates, and key starting materials. Ensure compliance with regulatory requirement and industry standards. Provide necessary support to plants for product trials, scale up, pilot batches. Provide technical support to tech transfer process and documentation. Continuous process improvement of API Collaborate with cross functional teams, Quality assurance, vendors, sum Ensuring a well-organized and safe laboratory environment while motivating others to uphold the same standards. Employ HPLC, GC, Mass spectrometry and NMR techniques to interpret and characterize product profiles. Perform feasibility studies, risk assessments, and process evaluations to foster continuous improvement and drive innovation. Extensive experience in a wide variety of chemical and dry reactions.

Assistant Manager Hyderabad 8 - 13 years INR 6.0 - 9.0 Lacs P.A. Work from Office Full Time

Roles and Responsibility: Free handling in ETP, MEE& Reverse osmosis plant (UF, NF, RO, NFRC,) And Production I also operated falling film and Forced circulation evaporators. Complete supervision of the operations of Zero Liquid Discharge Plant comprising Effluent treatment plant, Reverse Osmosis system (Ultra, Nano and Reverse osmosis filtration, NFRC), Thermal evaporation system (MEEs operations consisting of FFE, FCE, Spray dryer, ATFD etc.) and Incinerator. • Accountable for achievement of ZLD Performance. Establish continual improvement and optimization of the plant capacity through innovative engineering ideas, which can be done locally and in a cost- effective manner. • Highly motivated, innovative and acquiring good communication skills. • Pollution Control Board and Liasioning department documentation. • All safety related works. • Issuing work Permits & Issuing of PPE to employees and workmen • Identifying unsafe acts & conditions and creating safe working environment • Conducting Trainings for Employees and contract workmen as per schedules • Induction training for new employees based on general safety • Inspection of Eye wash & Eye wash showers regularly • Participating in Safety committee meeting quarterly • Improve housekeeping of plant by housekeeping drive. • Data storage of Effluent flow discharge, & VOC from APPCB site • Conducting Mock drills and fire drills • Conducting pre startup safety review through checklist before charging new batches • Inspection of Solvent tankers & hazardous waste carrying vehicles. • Basic First Aid for injured workmen. • Reports preparation like Daily/Weekly/Monthly reports and PCB related documentations preparation.

Assistant Manager Hyderabad 5 - 10 years INR 4.5 - 7.0 Lacs P.A. Work from Office Full Time

Roles & Responsibility : Demonstrated capabilities with various SCM operations, procurement, reduction raw material inventories, and business analytics. Production Planning techniques and continuous improvement practices in manufacturing under total productive maintenance, world class manufacturing and benchmarking Lead different cross-functional academic and professional projects, consistent performer with a strong track record, positive attitude, with ability to handle assignments under high pressure with accolades. New Vendor Development, Price Negotiation with vendor, PO releasing, Material Delivery and Payment, arranging samples, technical & DMF related documents etc. Created and processed purchase orders for all categories like RM, PM, R&D, RLD, FG, CAPITAL & ENGG etc. Tracked all orders placed with suppliers and inspected materials upon delivery to ensure that orders have been filled correctly and goods met specifications. Negotiated terms and conditions with vendors to ensure optimum price, competitiveness and high- quality products. Established procedures for managing return of damaged goods, replacement items, incomplete orders, shortages and appropriate credit arrangements. Preparing Price trend analysis, time management report & payment lists on regular basis. SKILLS & ABILITIES : Procurement of Material, and sourcing. Supply Chain planning & optimization. Strategic planning, forecasting & cost saving. introducing new vendors for RLD business. Implement ideas that lead to process improvements (cost, time, service improvement). Vendor Management, Negotiation with vendors, Ensure appropriate and adequate documentations in place for process &action. Strong communication abilities in person and in written. Strong knowledge of commodities.

Mis Executive Hyderabad 3 - 7 years INR 4.5 - 6.5 Lacs P.A. Work from Office Full Time

Role & responsibilities Proficiency in Data handling and generating report using Excel. Good at analyzing, gathering, managing and documenting business requirements. Experienced in data processing, validating and reporting. Proficiency in Excel - functions, Pivot tables and Charts, Dashboards. Good at combining multiple functions nested in single cell to create new set of variables. Expertise in using excel shortcuts to timely delivery of reports. Used in Advanced Excel the formulas : Vlook Up, Hlook UP, Pivort Tables, Len, Mid,Left, Right, Median, Index Match, Conditional format, Sumif , Countif , Sumifs, Countif and if Function.

Research And Development Chemist Hyderabad 0 - 5 years INR 1.75 - 5.0 Lacs P.A. Work from Office Full Time

Job Purpose: To carry out literature surveys, design synthetic routes, and perform multi-step organic synthesis for development and optimization of API molecules in line with regulatory and project timelines. Location : Hyderabad Department : Research & Development (R&D) API Division Reporting to : Manager Experience : 05 years (adjust based on requirement) Education : M.Sc. in Organic Chemistry Key Responsibilities : Route Design and Synthesis : Conduct literature and patent searches (e.g., using SciFinder, Reaxys). Propose and develop synthetic routes for new and existing APIs. Synthesize intermediates and APIs on lab scale. Process Development : Optimize reactions for yield, purity, and scalability. Participate in scale-up activities from lab to kilo lab and pilot plant. Develop cost-effective and environmentally friendly processes. Analytical Support : Work with Analytical R&D to characterize synthesized compounds (e.g., NMR, HPLC, GC, IR, MS). Prepare samples for stability and impurity profiling. Documentation : Maintain accurate and detailed lab notebooks. Draft technical documents: process development reports, technology transfer dossiers, etc. Ensure compliance with regulatory guidelines (ICH, GMP, etc.). Collaboration : Interact with cross-functional teams Analytical, Regulatory Affairs, QA/QC, and Manufacturing. Support technology transfer to manufacturing locations. Key Skills and Competencies : Strong theoretical and practical knowledge in organic synthesis and reaction mechanisms. Familiarity with GMP practices , regulatory norms (ICH Q11, Q7). Experience in reaction optimization , purification techniques , and problem solving . Proficiency in tools like SciFinder, Reaxys , and analytical instruments (HPLC, NMR, GC). Good communication skills and teamwork orientation. Ability to handle multiple projects and meet tight deadlines.

Team Lead Hyderabad 7 - 10 years INR 6.0 - 10.0 Lacs P.A. Work from Office Full Time

The Team Lead Process R&D (API) will be responsible for leading a team of scientists/chemists in the development, optimization, and scale-up of robust and cost-effective synthetic processes for Active Pharmaceutical Ingredients (APIs). The role includes overseeing lab experiments, technology transfer, and ensuring regulatory compliance for process development projects. Role & responsibilities Lead a team of scientists in developing and optimizing synthetic routes for APIs from lab scale to commercial scale. Design experiments (DOE) for process improvement, cost reduction, yield improvement, and impurity profiling. Monitor and review process parameters and data generated in the lab; provide technical guidance and troubleshooting support. Ensure development of scalable, safe, and reproducible processes aligned with GMP, safety, and environmental standards. Interface with cross-functional teams including Analytical R&D, Regulatory Affairs, Production, QA/QC, and Tech Transfer. Support scale-up activities in pilot plants and commercial manufacturing sites, including batch monitoring and documentation. Prepare and review technical documents including development reports, process protocols, risk assessments, and technology transfer documents. Guide team members in literature search (SciFinder, Reaxys), route selection, and patent landscape analysis. Maintain good documentation practices and ensure compliance with internal and external regulatory standards. Key Requirements: M.Sc. or Ph.D. in Organic Chemistry / Medicinal Chemistry / Pharmaceutical Sciences. 812 years of hands-on experience in Process R&D for APIs in a reputed pharmaceutical or CRO/CDMO company. Strong background in organic synthesis, reaction mechanism, and impurity identification and control. Proven experience in scale-up and tech transfer to pilot plant or production scale. Familiarity with QbD, DOE, cGMP, ICH guidelines, and regulatory requirements (USFDA, EMA). Good communication, leadership, and project management skills.

Project Manager Hyderabad,Telangana,India 0 years None Not disclosed On-site Full Time

Company Description Established in 2017, Aurore Life Sciences is a focused Active Pharmaceutical Ingredient (API) company delivering high-quality products in a regulatory compliant environment. Backed by manufacturing facilities in India with a combined capacity of 600 KL, and our flagship facility in Hyderabad, we are approved by USFDA, EDQM, WHO Geneva, COFEPRIS, KFDA and other regulatory agencies. Our facilities and dedicated R&D setup enable us to be a fully integrated API company, ensuring complete control of key starting materials, advanced intermediates, and final products. Aurore is becoming the preferred API and key API intermediates supply partner for leading global pharmaceutical companies, with a robust portfolio across major therapeutic divisions. Role Description This is a full-time on-site role for a Project Manager located in Hyderabad. The Project Manager will be responsible for overseeing and managing projects from initiation to completion, including expediting, inspection, logistics management, and ensuring that all project objectives are met within specified timelines and budgets. The role entails close coordination with internal teams and external partners, conducting regular project reviews, and ensuring compliance with safety and quality standards. Qualifications Project Management skills Expeditor and Expediting skills Inspection and Logistics Management skills Strong organizational and time management skills Excellent communication and leadership abilities Experience in the pharmaceutical industry is a plus Bachelor's degree in a relevant field or equivalent experience

Production Planning Inventory Control Hyderabad,Telangana,India 0 years None Not disclosed On-site Full Time

We are looking for a PPIC - AGM to join us at our corporate office, Hyderabad for an exciting opportunity. Company Description Established in 2017, Aurore Life Sciences is a focused Active Pharmaceutical Ingredient (API) company delivering high-quality products in a regulatory compliant environment. Backed by manufacturing facilities in India with a combined capacity of 600 KL, and our flagship facility in Hyderabad, we are approved by USFDA, EDQM, WHO Geneva, COFEPRIS, KFDA and other regulatory agencies. Our facilities and dedicated R&D setup enable us to be a fully integrated API company, ensuring complete control of key starting materials, advanced intermediates, and final products. Aurore is becoming the preferred API and key API intermediates supply partner for leading global pharmaceutical companies, with a robust portfolio across major therapeutic divisions. Purpose of the Role: Planning the production of a company in advance for the manufacturing process and controlling the raw materials in the inventory needed for producing finished goods. Usually, every manufacturing company has a department of production planning and inventory control to handle the planning and controlling process. Planning production schedules to ensure a smooth manufacturing process Creating and handling manufacturing orders Forecasting inventory requirements Reviewing sales forecasts and customer demands to understand the product demands in the market Scheduling production batches based on raw material level in the inventory and the production time Planning the procurement process based on the customer demand forecasting Monitoring stores raw materials and in the raw materials in the inventory and items stored in the warehouse. Monitoring receiving and delivering goods from the warehouse Planning production schedules to fulfil orders effectively taking planning time, routing and product quantities into account Managing machinery productivity and optimize machine productivity to avoid machine overuse or underuse Actively solve issues related to the production process effectively communicating with the marketing department and procurement department Analyzing and fulfilling capacity and requirements for resources in the production process. Monitoring stock levels in raw materials and finished products to ensure a smooth production process Providing inventory data to the accounting department. Qualifications Typically 15-20 years in API pharmaceutical manufacturing, supply chain, PPIC/PPMC functions; prior experience in a managerial or AGM-level planning role is expected. bachelor's or postgraduate degree (MBA/Operations/Supply Chain preferred/MSc) Strong experience with SAP PP/MM and Excel. Strong communication and interpersonal skills. Demonstrated initiative and willingness to learn.

Executive Environment Engineer hyderabad 8 - 10 years INR 4.5 - 5.0 Lacs P.A. Work from Office Full Time

ETP operations Preparation and submission of PCB documents Knowledge of Ecovadis preparation and submission Familiarity with ISO 14001 documentation Proficiency in MS Word and Excel Preparation and implementation of Environment SOPs as per operational needs Coordination with Jeedimetla and Kazipally team members for data collection and documentation

Fitter Technician hyderabad 1 - 5 years INR 2.0 - 4.0 Lacs P.A. Work from Office Full Time

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

AGM PPIC hyderabad 15 - 20 years INR 15.0 - 30.0 Lacs P.A. Work from Office Full Time

Purpose of The Role: Planning the production of a company in advance for the manufacturing process and controlling the raw materials in the inventory needed for producing finished goods. Usually, every manufacturing company has a department of production planning and inventory control to handle the planning and controlling process. Key Responsibilities : Planning production schedules to ensure a smooth manufacturing process Creating and handling manufacturing orders Forecasting inventory requirements Reviewing sales forecasts and customer demands to understand the product demands in the market Scheduling production batches based on raw material level in the inventory and the production time Planning the procurement process based on the customer demand forecasting Monitoring stores raw materials and in the raw materials in the inventory and items stored in the warehouse Monitoring receiving and delivering goods from the warehouse Planning production schedules to fulfil orders effectively taking planning time, routing and product quantities into account Managing machinery productivity and optimize machine productivity to avoid machine overuse or underuse Actively solve issues related to the production process effectively communicating with the marketing department and procurement department Analyzing and fulfilling capacity and requirements for resources in the production process. Monitoring stock levels in raw materials and finished products to ensure a smooth production process Providing inventory data to the accounting department. Preferred candidate profile : Bachelor's or postgraduate degree (MBA/Operations/Supply Chain preferred/ MSc). Proficiency in SAP PP/MM, Power BI, advanced Excel. Strong analytical, leadership, and stakeholder engagement skills. Demonstrated expertise in pharma manufacturing environment.

Business Development Manager hyderabad 10 - 15 years INR 10.0 - 20.0 Lacs P.A. Work from Office Full Time

Job Description: Position: Business Development manager Exp: min 10 Years Location: Hyderabad Key Role and Responsibilities Conduct thorough market research to identify potential business opportunities, market trends, and competitor analysis. Analyse market dynamics and regulatory environment to identify key areas for business development initiatives. Develop and implement strategic business plans to expand the company's presence in the pharmaceutical sector. Identify and prioritize target markets, customer segments, and product opportunities based on market analysis. Identify and engage with potential clients, partners, and stakeholders through various channels such as networking events, conferences, and cold outreach. Build and maintain a robust pipeline of qualified leads and opportunities. Lead negotiations with potential partners, including licensing agreements, collaborations, and distribution agreements. Work closely with legal and finance teams to finalize terms and contracts. Cultivate and maintain strong relationships with key stakeholders, including pharmaceutical companies, regulatory bodies, research organizations, and healthcare professionals. Serve as the primary point of contact for existing and prospective clients, addressing their needs and ensuring high levels of customer satisfaction. Collaborate closely with internal teams including marketing, sales, product development, and regulatory affairs to ensure alignment and support for business development initiatives. Provide insights and feedback to support the development of new products and services tailored to market needs. Prepare regular reports and updates on business development activities, including pipeline status, progress against targets, and market insights. Analyse key performance indicators (KPIs) to assess the effectiveness of business development strategies and identify areas for improvement. Requirements: Bachelor's degree in Science/Business Administration/Marketing, or a related field. MBA preferred. Proven experience in business development, sales, or marketing within the pharmaceutical industry, with a focus on APIs. Strong understanding of the pharmaceutical market, industry trends, and regulatory requirements. Excellent communication, negotiation, and interpersonal skills. Leadership skills is a must Willingness to travel as needed.

Production Chemist hyderabad/ secunderabad 1 - 5 years INR 2.0 - 3.5 Lacs P.A. Work from Office Full Time

Execution of the Batch production records like MBPRs, Cleaning BPRs etc Indent and receipt of raw materials and general items Plan the Batch movement as per schedule and maintain the records as per standard operating procedures. Follow the validations as per protocols (Process /Cleaning) Ensuring the raw materials and intermediates storage and handling as per defined procedure/ Instruction.

Senior Research Associate hyderabad 3 - 5 years INR 3.0 - 5.0 Lacs P.A. Work from Office Full Time

Roles And Responsibility : Develop and execute laboratory experiments to successfully complete customer projects. Conducting feasibility studies, optimizing, and scaling up reactions for the synthesis of APIs, and key starting materials. Ensure compliance with regulatory requirement and industry standards. Provide necessary support to plants for product trials, scale up, pilot batches. Provide technical support to tech transfer process and documentation. Continuous process improvement of API Collaborate with cross functional teams, Quality assurance, vendors, sum Ensuring a well-organized and safe laboratory environment while motivating others to uphold the same standards. Employ HPLC, GC, Mass spectrometry and NMR techniques to interpret and characterize product profiles. Perform feasibility studies, risk assessments, and process evaluations to foster continuous improvement and drive innovation. Extensive experience in a wide variety of chemical and dry reactions.

Business Development Manager hyderabad 10 - 15 years INR 15.0 - 30.0 Lacs P.A. Work from Office Full Time

Job Title: Business Development Manager (Market Lead) Division: Corporate Department: Business Development Market : Preferably someone having regulatory market exposure specifically Europe. Location: Hyderabad Team Size: 1 (Expandable to 3) Role Summary We are seeking a dynamic and experienced Business Development Manager (Market Lead) to spearhead our growth initiatives and expand our market presence in the pharmaceutical industry. This strategic role involves identifying new business opportunities, nurturing client relationships, and forging partnerships to promote Aurores API product lineparticularly in regulated international markets. Key Responsibilities Identify and pursue new business opportunities within the pharmaceutical industry, focusing on APIs Develop and implement strategic business development plans to meet sales targets and grow market share Build and maintain strong relationships with key clients, partners, and stakeholders Conduct market research and competitive analysis to inform strategy and product positioning Collaborate with cross-functional teams (R&D, Regulatory, Production) to deliver tailored solutions to clients Represent Aurore Life Sciences at industry events, conferences, and trade shows Negotiate contracts, pricing, and commercial terms to ensure mutually beneficial outcomes Monitor industry trends, regulatory changes, and market dynamics to guide business decisions Candidate Profile Qualifications & Experience Bachelors degree in Science, Business Administration, Marketing, or related field; MBA preferred Advanced degree in Pharmacy, Chemical Engineering, Organic Chemistry, Biochemistry , or related discipline Minimum 06 years of experience in pharmaceutical business development, preferably in API manufacturing Proven track record of client acquisition, revenue growth, and strategic market expansion Skills & Competencies Deep understanding of the API business and global pharmaceutical landscape Strong grasp of market dynamics and regulatory frameworks that drive sustainable growth Extensive network of scientific and business contacts in the pharmaceutical sector Exceptional communication, negotiation, and interpersonal skills Public speaking proficiency to represent the organization at external forums Willingness to travel internationally as required

IPQA - Assistant Manager hyderabad 6 - 10 years INR 5.0 - 10.0 Lacs P.A. Work from Office Full Time

Job Title: Assistant Manager In-Process Quality Assurance (IPQA) Department: Quality Assurance Location: Hyderabad, Jeedimetla Reporting To: Manager Quality Assurance / Head Quality Job Purpose: To ensure that all in-process operations are monitored and compliant with applicable cGMP, SOPs, and regulatory requirements. The IPQA Assistant Manager is responsible for in-line quality checks, deviation control, batch record review, and timely escalation of non-conformities during manufacturing and packaging processes. 1. In-Process Quality Monitoring Supervise and execute IPQA activities during manufacturing and packaging. Perform real-time line clearance, process checks, and verification. Ensure compliance with Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR). 2. Documentation and Compliance Review in-process documents for accuracy and completeness. Ensure that manufacturing and packaging operations are performed as per SOPs and GMP guidelines. Maintain and archive IPQA records in a compliant manner. 3. Deviation & Change Control Identify, report, and investigate deviations, non-conformities, and incidents. Assist in the implementation of CAPA (Corrective and Preventive Actions). Coordinate with production, quality control, and other departments to resolve quality issues. 4. Audits & Regulatory Compliance Assist during internal, external, and regulatory audits (e.g., USFDA, MHRA, WHO). Ensure readiness of IPQA documentation and process compliance. Implement audit recommendations in coordination with QA leadership. 5. Training & Team Management Train IPQA staff and production teams on quality systems, SOPs, and GMP. Supervise IPQA officers/inspectors and ensure their optimal performance. Promote a culture of quality and continuous improvement on the shop floor. Key Skills and Competencies: Strong knowledge of cGMP, GDP, and regulatory standards (USFDA, MHRA, WHO-GMP, etc.) Excellent documentation and communication skills. Experience with QMS tools (e.g., deviation, change control, CAPA systems). Ability to lead and coordinate cross-functional teams. Qualifications: B.Pharm / M.Pharm / B.Sc / M.Sc in Chemistry, Microbiology, or related discipline. Experience: Minimum 6-10 years of relevant experience in IPQA, preferably in pharmaceutical manufacturing (API).

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