149 Sterile Jobs - Page 2

Must to have Exp into sterile (injectables) production Prepare & review SOPs Responsible for daily smooth operation of Production Lead & Collaborate to implement process improvements, automation initiatives, and technology upgrades effectively Required Candidate profile Good in Communication Good in Leadership Quality

Novo Nordisk Global Business Services (GBS) India Department GCM DP RoW Job Location Hyderabad Are you an expert in aseptic manufacturing with a strong quality mindset and a desire to make a tangible impact on global healthNovo Nordisk is seeking a dedicated Manufacturing Specialist to join our Global Contract Manufacturing Drug Product (GCM DP) team in Hyderabad, India. In this role, you''ll be crucial in ensuring the high-quality production of life-saving insulin and GLP-1 products through our Contract Manufacturing Organizations (CMOs). ! The Position As a Manufacturing Specialist (SME), you''ll be the go-to expert driving Technology Transfer projects for commercial products, ensuring top-tier quality with our Contract Manufacturing Organizations (CMO) partners. Your key responsibilities will include: Lead cross-functional teams, ensuring seamless collaboration between Novo Nordisk as the sending Unit and Contract Manufacturing Organizations (CMOs) partners as the receiving Unit. Act as a mentor and support Contract Manufacturing Organizations (CMOs) to ensure Novo Nordisk products are manufactured to the highest quality standards. Provide training, share best practices, and review and approve validation documents to safeguard compliance. Offer oversight and support during the planning and execution of validation and qualification activities. Define, manage, and deliver on complex projects in collaboration with CMOs, Quality Assurance, and project managers. Drive problem-solving initiatives and provide scientific and technical solutions within tight project timelines. Qualifications Bachelor’s /Master’s degree in engineering. Possess 10+Years experience and relevant 5 years of manufacturing experience, especially in an international, multicultural environment. Expertise in aseptic manufacturing processes is non-negotiable. Capable of communicating naturally and effectively with stakeholders at all levels with adept at finding solutions and motivating stakeholders to achieve ambitious goals. Possessing a strong mindset, a focus on continuous improvement, and keen attention to detail. Demonstrates the ability to work independently with minimal supervision, a strong willingness to learn new skills, and the motivation and flexibility to thrive in a fast-paced, dynamic environment. About the Department GCM DP RoW Projects is dedicated to delivering life-saving insulin and GLP-1 to patients in regions such as Africa, India, the Middle East, and Asia. By partnering with CMOs in these areas, the department plays a pivotal role in improving the quality of life for patients living with diabetes and obesity. With a focus on Market Access initiatives, the team tailors projects to meet the unique requirements of each country, offering exciting growth opportunities. The department thrives on innovation and problem-solving, overcoming challenges and navigating complex regulatory landscapes to deliver insulin and GLP-1 on a global scale. Based in Hyderabad, India, you’ll join a diverse and dynamic team committed to making a difference.

Novo Nordisk Global Business Services (GBS) India Department: GCM DP RoW Location Hyderabad, India Are you an experienced aseptic manufacturing project manager with a strong technical background and a passion for making a direct impact on patients'' livesDo you thrive in an international environment where cultural awareness is key to your successIf so, this could be your dream role! ApplyNow! The Position As a Project Manager in Aseptic Manufacturing, you will lead and mentor cross-functional teams, including both Novo Nordisk and our Contract Manufacturing Organisation (CMO) partners. It includes, Ensure the seamless Technology Transfer and manufacturing of our commercial products, always upholding Novo Nordisk''s stringent quality standards and adhering to cGMP and regulatory requirements. Lead and manage aseptic manufacturing projects, specifically leveraging your expertise in areas like Formulation/Compounding, Filling, Washing & Sterilisation, Environmental Monitoring, or Clean Utilities. Developing and managing detailed project plans and timelines and communicating effectively with steering groups and key stakeholders. Monitoring progress and proactively securing necessary resources. Developing project risk grids and identifying mitigation strategies with both Novo Nordisk and our Contract Manufacturing Organisation (CMOs). Qualifications Bachelor’s or Master’s degree in engineering. Possess experience of 5-12Years of project management experience with a proven track record of successful project delivery in a highly regulated environment, especially internationally. Aseptic manufacturing experience is a must, and experience with Technology Transfer of biologics is a significant advantage. Professional experience balancing individual drive with effective stakeholder involvement. Proficiency in project management software (e.g., MS Project, Smartsheet, Jira, or equivalent). Demonstrated fluency in written and spoken English is essential. About the Department GCM DP RoW Projects is a dedicated team committed to providing life-saving insulin and GLP-1 to patients in regions such as Africa, India, the Middle East, and Asia. By partnering with CMOs in these areas, the department strives to make a meaningful impact on the quality of life for patients living with diabetes and obesity. Our projects are tailored to meet the unique requirements of each country, offering exciting growth opportunities. With a steadfast commitment to innovation and problem-solving, we work to overcome challenges and navigate complex regulatory landscapes to deliver insulin and GLP-1 on a global scale. Join us in making a difference.

Senior Manager Quality Assurance – Formulation Injectables Quality Assurance – Sterile Formulations Reports To: Cluster Head – QA Qualification: M.Sc / M.Pharm (Pharmaceutical Sciences / Quality Assurance / Microbiology or related) Experience: 15–20 years of experience in Quality Assurance for sterile injectable formulation manufacturing. Job Purpose: To lead the Quality Assurance function for sterile injectable formulations by ensuring effective implementation of quality systems, compliance with regulatory requirements, and oversight of batch release, documentation, validation, and all related QA activities in a cGMP-compliant environment. Key Responsibilities: 1. Quality Oversight & Team Leadership Lead QA functions across sterile injectable manufacturing lines. Allocate responsibilities and monitor performance of QA team members. Ensure adherence to cGMP, quality systems, and regulatory compliance. 2 . Batch Release & Documentation Control Review and approve Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and analytical data. Perform batch disposition (release or reject) based on thorough quality review. Ensure control and lifecycle management of documents such as SOPs, BMRs, BPRs, STPs, and specifications. 3 . Quality Management System (QMS) Develop, review, and upgrade QMS policy documents like Site Master File (SMF), Quality Manual, and Cross-Contamination Strategy. Monitor and review QMS activities such as: Change Controls Deviations CAPA (Corrective and Preventive Actions) OOS/OOT Market complaints and recalls APQR (Annual Product Quality Review) 4. Validation & Qualification Ensure execution and compliance of validation programs: Process validation Cleaning validation Equipment qualification (IQ, OQ, PQ) Facility and utility qualification Define IPQA procedures and oversee their effective execution. Review and approve validation protocols and reports. 5. Regulatory Compliance & Audit Readiness Ensure readiness for national and international regulatory inspections (USFDA, MHRA, EU-GMP, WHO). Prepare and review responses to inspection observations. Guide QA teams during internal and external audits. 6. Calibration, Maintenance & Environmental Monitoring Review schedules and compliance for calibration of instruments and preventive maintenance of equipment. Ensure compliance with environmental monitoring and microbial controls in sterile areas. 7. Electronic Systems & Quality Tools Review and approve documents generated electronically via platforms such as: DMS (Document Management System) QAMS (Quality Assurance Management System) LIMS (Laboratory Information Management System) NICHELON, CLEEN, or other enterprise QMS tools 8. Training & Continuous Improvement Identify training needs for QA staff and ensure implementation. Drive continual improvement initiatives in quality systems and compliance culture. Key Skills & Competencies: Strong knowledge of aseptic/sterile injectable formulation processes Deep understanding of global regulatory guidelines (USFDA, EMA, WHO, etc.) Excellent documentation and data integrity compliance Leadership, team management, and decision-making abilities Proficient in use of electronic QMS tools Preferred Candidate Profile: Successfully led QA functions for sterile injectable manufacturing facilities. Handled regulatory audits (USFDA, EU, MHRA, TGA, WHO). Experience in technology transfer and product lifecycle management. Ability to interface effectively with cross-functional teams (QC, Production, RA, Engineering).

Walk-in @ Indore We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned, If any of the requirement is matching your current job profile, kindly walk-in with your latest resume. *Job Location: Matoda, Ahmedabad, Gujarat. Engineering (Instrumentation / QMS / Process Equipment maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification BE / B Tech with relevant functional experience in Calibration / Instrumentation / QMS activities QUALITY ASSURANCE QMS / Documentation / Validation and Qualification / IPQA (OSD) (Officer / Senior Officer / Executive/Senior Executive) Experience - 02 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. QUALITY CONTROL (Officer / Senior Officer/ Executive) Experience - 02 to 07 Years Education - B.sc / M.Sc. (Organic Chemistry / Analytical Chemistry) B. Pharmacy / M Pharmacy MICROBIOLOGY (Officer / Senior Officer/ Executive) Experience - 02 to 07 Years Education - B.sc / M. Sc (Microbiology) Injectable Manufacturing (Executive/Senior Officer / Officer / Associate) Experience - 01 to 06 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma with relevant functional experience in injectable manufacturing/ Aseptic area operations / Visual inspection / QMS activities OSD Manufacturing (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Diploma with relevant functional experience in OSD manufacturing operations / QMS activities Time and Venue : 20th July 2025 09:30 Hrs to 18:00 Hrs ______________________________________________________ PAPAYA TREE Group of Hotels - Indore, Address: AB Road , Near Dr. Hardia Eye Clinic, Rau, Indore, MP ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. Note: Having relevant qualification only can attend the scheduled walk-in.

1. Instrument Decontamination: Receive used medical instruments and equipment from various hospital departments and decontaminate them using mechanical cleaners, ultrasonic machines, or manual cleaning as appropriate. 2. Sorting and Inspection: Sort, inspect and disassemble contaminated instruments, checking for damage or wear and ensuring that they are suitable for sterilization. 3. Sterilization: Operate and monitor sterilization equipment such as autoclaves and ethylene oxide (EtO) chambers, following established procedures to ensure the instruments are properly sterilized. 4. Packaging: Properly package sterilized instruments and equipment, ensuring that they remain sterile during storage and transport. 5. Inventory Management: Maintain an accurate inventory of instruments and equipment, including tracking expiration dates for sterilization supplies. 6. Quality Control: Perform routine tests and checks to verify the effectiveness of sterilization processes and ensure compliance with established standards. 7. Documentation: Maintain detailed records of instrument processing, sterilization cycles and quality control checks. Document any issues or incidents. 8. Equipment Maintenance: Ensure that sterilization equipment is properly maintained and report any malfunctions or maintenance needs to the appropriate department. 9. Safety and Infection Control: Adhere to strict infection control practices and safety protocols to protect patients and healthcare staff from exposure to infectious agents. 10. Collaboration: Work closely with other hospital departments, including surgery, nursing and clinics, to meet their instrument and equipment needs. 11. Continuing Education: Stay updated on the latest advances in sterilization techniques, equipment and infection control practices. 12. Emergency Response: Be prepared to Handle instrument recalls and investigate any infection outbreaks related to contaminated instruments. Role & responsibilities Qualification HSC/ Any Graduate - Dip in CSSD Preferred candidate profile

Job Title: Manager / Sr. Manager Engineering (Projects) Location : Central India (Greenfield Project) Responsibilities- Overall experience in USFDA Injectable Plants, handling Qualification of HVAC, Designing, Installation, Commissioning Clean Utilities Black Utilities Overall, In charge of Piping, Utilities & HVAC Systems for installations at Site. Based on the received drawings & documents, assign work and timelines and ensures the implementation of the same. Ensure collection of data; do analysis to achieve relevant construction quality and safety. Help overcome constraints, work out alternatives to the design in case of difficulties Retention of records in respective area. Preparation & completeness of documentation for Qualifications. Give final acceptance of construction quality for piping and utilities. Review measurements sheets. Ensure schedule updates in primavera and send progress reports in terms of schedule work quantity, progress, constraints, snaps and etc. Coordination with Boiler Inspector and other statutory agencies Execute construction quality audits for piping and utilities. Responsible for construction quality; finishes, Operations, Performance and safety at site. He will report quantity variation and scope change Educational Qualification Bachelor's degree in Mechanical Engineering Experience : Tenure : 14 to 17 Years ( Pharmaceutical Industry with Injectable experience mandatory)

Roles and Responsibilities Operate autoclave equipment to sterilize medical instruments and equipment according to established protocols. Perform cleaning, washing, and drying procedures on surfaces and objects using various cleaning solutions. Ensure proper functioning of all CSSD (Central Sterile Supply Department) equipment by performing routine maintenance tasks. Maintain accurate records of inventory management, including tracking stock levels, ordering supplies, and receiving deliveries. Collaborate with other team members to ensure efficient workflow and maintain high-quality standards. Desired Candidate Profile 3-8 years of experience in a hospital setting with exposure to CSSD operations. Diploma or equivalent qualification in relevant field (e.g., NABH). Strong understanding of sterile techniques, sterilization methods (autoclave), quality control measures. Ability to work effectively under pressure while maintaining attention to detail.

Experience: 2 to 10 years of sterile area / injectables Manufacturing experience in a reputed organization Technical knowledge: -Good Technical knowledge in oRABS-Vial filling line and practical experience in handling the injectables manufacturing Equipment. -Worked in USFDA and EMA regulatory approved companies -Excellent quality oriented and result oriented attitude -Good experience in cGMP and GDP

Greetings from Adecco , A Leading Manpower Consulting Company!!! We have been retained by Leading Pharmaceuticals Company in Ahmedabad for their Manpower Requirements. We have an following Openings as of now. 1) Vial Washing Operator 2) Filling Machine Operator 3) Aseptic Operator 4) Autoclave Education: ITI/Diploma Experience: 3 to 10 Years. Interested candidates please connect on below contact details.

Walk-in at Matoda Were currently recruiting for multiple positions at our SANAND manufacturing facility. If any role aligns with your experience, please bring your updated resume and walk in during the scheduled drive. Please find our current job requirements and venue details mentioned. Requirement : Injectable Manufacturing & Visual Inspection Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI Time and Venue : 12th June 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. *Having relevant qualification only can attend the scheduled walk-in.

Walk-in at Matoda Were currently recruiting for multiple positions at our SANAND manufacturing facility. If any role aligns with your experience, please bring your updated resume and walk in during the scheduled drive. Please find our current job requirements and venue details mentioned. Requirement : Injectable Manufacturing & Visual Inspection Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI Time and Venue : 12th JULY 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. *Having relevant qualification only can attend the scheduled walk-in.

Formulation/ Vaccine/ Sterile Drug Product Manufacturing Qualification requirement: M.Sc/B.Sc (Life Science) B.Pharm/M.Pharm Diploma / ITI (Experience in aseptic operation) Fresher's & Experienced (1 5 Years) Formulation Filling (Vials , BFS, PFS) Vial Washing, Depyrogenation Sealing & Capping Sterile aseptic operation C- Rabs, O-Rabs, Isolator Autoclave operation SOP/BMR/QMS

Walk In Drive For Production Injectables In Formulation Division @ Kothur Department:- Production Injectables Qualification :- Diploma | ITI | B Tech | B Pharmacy | BSc | MSc | M Pharmacy Experience :- 2 to 8 Years Skills :- Filling Operator Division :- Formulation Interview Date:12-07-2025 Interview Time :- 9.00AM TO 2.00PM Work Location:- Unit-II, Kothur Venue Location :- Survey Nos.1277 & 1319 to 1324, Nandigama (Village), Kothur (Mandal, Mahbubnagar, Telangana 509001) Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.

-Operation of Vial/Ampoule washing machine -BMR -Classified area monitoring -validation of the machine Interested candidates can share resume on dipika.parmar@milanlabs.com

-Operation of Vial/Ampoule filling machine -BMR -Classified area monitoring -validation of the machine Interested candidates can share resume on dipika.parmar@milanlabs.com

-Operation of Lyophilizer machine -BMR -Classified area monitoring -validation of the machine Interested candidates can share resume on dipika.parmar@milanlabs.com

Should have minimum 1-4 years of experience in Production Injectable (Small Volume Parentral). Immediate Joiners will be preffered. Interested candidates can share resume on dipika.parmar@milanlabs.com

Role & responsibilities Develop, execute, and document qualification protocols (DQ/IQ/OQ/PQ) for equipment, utilities, and facilities. Collaborate with Engineering, Production, QA, Or other Cross functional teams to coordinate qualification activities. Maintain qualification documentation, including risk/impact assessments and change-control records. Ensure compliance with USFDA, MHRA, WHOGMP, and ICH Q9/Q10 standards. Support internal and external audits and inspections focused on qualification. Diagnose deviations in qualification processes and initiate CAPAs. Manage and update the Qualification Master Plan and requalification schedules. Specialize in injectable product qualification (media fill, aseptic simulation, smoke studies). Oversee qualification of systems such as water, steam, HVAC, filling/sealing machines, autoclaves, isolators, washing tunnels/DHS units, and more Preferred candidate profile Deep knowledge of qualification and validation best practices (equipment, utilities, facilities) and Hands-on experience with media fill/aseptic simulation, smoke studies, and utilities (water, steam, HVAC). Proficient in URS/DQ/IQ/OQ/PQ processes for various equipment (vial/ampoule washers, filling/sealing units, autoclaves, isolators). Strong understanding of equipment qualification, utility validation, and cleanroom classification. Familiarity with cGMP, data integrity (ALCOA+), and GxP documentation standards. Competent in creating/reviewing technical documentation and qualification protocols in line with regulatory requirements. Excellent analytical and problem-solving skills, with a methodical attention to detail. Proven ability to collaborate cross-functionally and interface confidently during audits and inspections.

Job Description: Regulatory Affairs Assistant Manager / Manager Injectable & OSD Facility Department: Regulatory Affairs Location: GIDC Ankleshwar Key Responsibilities: Prepare and submit dossiers (CTD/ACTD) for ROW & US markets. Ensure compliance with local regulatory guidelines and GMP standards. Liaise with regulatory agencies and respond to queries promptly. Manage product registrations, renewals, and variations. Monitor regulatory updates and ensure adherence to changes. Support quality audits and review labeling/artwork for compliance .

Position: Production Executive / Officer Injectables Location: Ankleshwar,Gujarat Experience: 2-4 years Key Responsibilities: Carry out production activities as per SOPs and schedule Ensure adherence to cGMP and regulatory guidelines Maintain accurate production documentation (BMRs, logbooks) Coordinate with QA/QC for line clearance and sampling Support equipment cleaning, operation, and minor troubleshooting Follow all safety and hygiene protocols Requirements: B.Pharm/M.Pharm/B.sc/ Msc or equivalent 2- 4years experience in parental production Good knowledge of GMP and pharma documentation Strong attention to detail and communication skills

The CSSD Technician is responsible for the effective sterilization and disinfection of surgical instruments and medical equipment. This role involves preparing, sterilizing, and ensuring the safe handling of instruments to maintain the highest standards of hygiene and safety within the hospital environment. The technician will also be responsible for the quality control of sterilization processes and will work closely with various departments to support surgical procedures. Roles and Responsibilities - Clean, decontaminate, and sterilize instruments and medical equipment using appropriate methods and technologies. - Ensure the proper functioning of sterilization equipment and report any malfunctions. - Monitor and maintain sterilization logs and quality assurance records. - Prepare and package instruments for surgery, following established protocols. - Collaborate with surgical teams to meet instrument and equipment needs during procedures. - Follow infection control standards and safety protocols to prevent contamination. - Conduct routine checks and maintenance of CSSD supplies and inventory management. - Participate in ongoing training and professional development related to sterilization techniques and infection control practices. Skills Required: - Knowledge of sterilization techniques, principles of infection control, and safety standards. - Familiarity with surgical instruments and medical equipment. - Attention to detail and strong organizational skills. - Ability to work under pressure and manage time effectively. - Excellent communication and teamwork skills. - Analytical skills to monitor sterilization processes and troubleshoot issues. Tools and Equipment: - Autoclaves and sterilization equipment. - Decontamination tools and instruments. - Personal protective equipment (PPE). - Inventory management software. - Quality control systems and logging tools.

Role & responsibilities : Supervise sterile manufacturing processes such as compounding, filtration, filling, and sealing of injectable products. Ensure compliance with cGMP, FDA, and other regulatory requirements in all production activities. Monitor and control environmental conditions in aseptic areas, ensuring cleanroom discipline is maintained. Coordinate with quality control, quality assurance, and engineering departments for production-related activities. Review and maintain batch manufacturing records (BMR), logbooks, and other relevant documentation. Perform in-process checks and ensure timely reporting of deviations and non-conformances. Assist in validation activities including media fill, equipment qualification, and process validation. Train and guide production staff on aseptic techniques, gowning procedures, and SOP adherence. Ensure timely availability of materials, equipment, and manpower for smooth production operations. Participate in internal and external audits and support compliance initiatives. Preferred candidate profile Education: B.Pharmacy/ M.Sc. Experience: 1-7 years in injectable (sterile) production in a pharmaceutical company. Knowledge of aseptic processing and cleanroom protocols. Familiarity with equipment like autoclaves, vial washers, filling lines, lyophilizers, and isolators. Understanding of documentation and regulatory requirements (e.g., USFDA, EU GMP, WHO GMP).

Role & responsibilities For Production : Having Injectable Experience of Shop floor activities like Filling, Sealing, Stoppering, Garment Washing Machine, Vial Washing, Autoclave, Ophthalmic, Suspensions (Handling of Homogenizer, Netzsch Mill/Bead Mill and Single use Systems) filtration, Lyophilizes. Having Injectable Experience of Shop floor supervising activities like Filling, Sealing, Stoppering, Garment Washing Machine, Vial Washing, Autoclave, Ophthalmic, Suspensions (Handling of Homogenizer, Netzsch Mill/Bead Mill and Single use Systems) filtration, Lyophilizes. Operations and Training and QMS. For Quality Assurance : Having Injectable Experience of QMS, Audit & Compliance, IPQA, AQA (Microbiology), CSV Validations

Role & responsibilities 15 to 20 years of relevant industry experience. Must have experience working in organizations supplying to the USA and EU markets. Must have participated in at least 5 successful USFDA audits. Hands-on experience in sterile formulations, including vials, pre-filled syringes, and ophthalmic solutions. Exposure to working with isolators is essential. Comprehensive experience in managing Quality Management Systems, including Change Control, Deviations, CAPA, and Annual Product Quality Reviews (APQR). Overall responsibility for IPQA activities and batch release processes. Handling compliance-related activities, including internal audits and external regulatory inspections. Responsible for the training and development of the quality team.