241 Osd Jobs - Page 8

Role & responsibilities Knowledge of Blister Packing machine Knowledge of Bottle Packing machine Knowledge of GDP / GMP Knowledge of Production Packing

Regulatory Functional: Compilation of dossier for ROW market as per the country specific requirements (from Module-1 to Module 5) Ensure compliance to county specific regulatory requirements (i.e., Africa, ASEAN, CIA, Gulf, Asia pacific, Latin America) ¢ Ensure labeling compilation as per the country specific requirements ¢ Review of DMFs of complex peptide drug substances ¢ Post approval activity, variation filing (Major and Minor) as per change proposal recommend by the manufacturing site or client ¢ Experienced with handling drug device combination regulations and understand the requirements for submission in line country specific requirement (Prefilled syringes and disposable pens) ¢ To assure consistency and adequacy of submissions in line with current regulatory requirements/expectations ¢ Ensure timely response to the deficiencies received from the agencies ¢ To communicate & coordinate with different stakeholders within the organization/ third party contract manufacturers to resolve any delay in submissions ¢ Life cycle management of products to include renewals, reviewing & approving the change controls and ensures product continuity through filing and timely approvals of variations. Support the continuing activities through coordination with various stakeholder ¢ Approval package compilation and provides support for lunching of the approved product

We are looking for a seasoned Quality Assurance Head to champion quality and compliance at Reputed Pharmaceutical Company, ensuring the highest standards in pharmaceutical manufacturing. As QA Head, you will spearhead the establishment and maintenance of robust Quality Management Systems (QMS) aligned with global regulatory standards (EU GMP, US FDA, MHRA, WHO). Your leadership will be pivotal in managing internal and external audits, driving CAPA implementation, and overseeing deviation investigations to maintain product integrity. The ideal candidate will possess a deep understanding of cGMP, ICH guidelines, and QbD principles, coupled with exceptional leadership and communication skills. You will play a critical role in ensuring regulatory compliance, managing supplier quality, and fostering a culture of continuous improvement within the QA team. You will ensure compliance with cGMP, GLP, GDP guidelines, batch release and documentation, and also lead regulatory inspections. If you are passionate about quality, possess a strategic mindset, and thrive in a dynamic pharmaceutical environment, we encourage you to apply and lead Evertogen towards excellence in quality assurance. Job Details: Industry: Pharmaceutical Department: Quality Assurance Role: Quality Assurance Head Location: Jadcherla Compensation: Up to 30,00,000/Annum Experience: Above 15 Years Employment Type: Full-time Qualification: Bachelor's/ Master's in Pharmacy or Chemistry Responsibilities: Quality Systems & Compliance Establish, implement, and maintain a robust Quality Management System (QMS) compliant with EU GMP, US FDA, MHRA, WHO, and other relevant regulatory requirements. Oversee the development, review, and approval of Standard Operating Procedures (SOPs) and other quality-related documentation. Lead and manage internal audits to assess compliance with cGMP guidelines and identify areas for improvement. Ensure adherence to data integrity principles and practices across all quality-related activities. Represent the company during regulatory inspections and customer audits, ensuring effective communication and resolution of findings. Monitor and report on key quality metrics, identifying trends and implementing corrective actions as needed. Batch Release & Documentation Review and approve Master Batch Records (MBRs), Batch Manufacturing Records (BMRs), and Batch Packaging Records (BPRs) to ensure accuracy and completeness. Oversee the timely release of batches, ensuring compliance with all applicable regulatory requirements and quality standards. Manage the documentation control system, ensuring proper storage, retrieval, and archival of quality records. Ensure all documentation is in compliance with cGMP principles and regulatory guidelines. Collaborate with production and other departments to resolve any issues related to batch documentation or release. Implement and maintain systems to track and trend batch release metrics, identifying areas for improvement. Deviation, CAPA & Change Control Lead investigations into deviations, out-of-specification (OOS) results, and out-of-trend (OOT) results, identifying root causes and implementing corrective actions. Manage the Corrective and Preventive Action (CAPA) system, ensuring timely and effective resolution of quality issues. Review and approve change control requests, assessing the potential impact on product quality and regulatory compliance. Monitor the effectiveness of CAPA plans and change control implementations, ensuring that they achieve the desired results. Collaborate with cross-functional teams to identify and implement preventive actions to minimize the risk of future deviations. Ensure all deviations, CAPAs, and change controls are documented and tracked in accordance with company procedures. Regulatory & Customer Audits Serve as the primary point of contact for regulatory agencies during inspections, managing the audit process and responding to inquiries. Lead the preparation for and conduct of customer audits, ensuring compliance with client requirements and expectations. Review and approve responses to regulatory observations, audit findings, and market complaints, ensuring timely and effective resolution. Maintain up-to-date knowledge of regulatory requirements and industry best practices, ensuring that the company remains in compliance. Develop and implement strategies to improve the company's audit readiness and overall compliance posture. Establish and maintain strong relationships with regulatory agencies and customers. Supplier & Vendor Qualification Oversee the vendor qualification program, ensuring that all suppliers of raw materials, packaging materials, and contract services meet the company's quality standards. Conduct audits of suppliers and vendors, assessing their compliance with cGMP guidelines and other regulatory requirements. Review and approve supplier quality agreements, ensuring that roles and responsibilities are clearly defined. Monitor supplier performance, identifying and addressing any quality issues or concerns. Collaborate with procurement and other departments to ensure that supplier quality is a key factor in sourcing decisions. Maintain a list of approved suppliers and vendors, ensuring that all are qualified and meet the company's standards. Training & Team Management Develop and implement training programs for QA, production, and other relevant departments on cGMP, data integrity, and regulatory requirements. Lead, mentor, and develop a high-performing QA team, fostering a culture of continuous improvement and collaboration. Conduct performance reviews and provide feedback to team members, identifying areas for development and growth. Ensure that all QA personnel are properly trained and qualified to perform their assigned duties. Promote a culture of quality and compliance throughout the organization. Manage the QA budget, ensuring that resources are allocated effectively to support the company's quality goals. General Expectations and Past Experiences: Possess a Bachelor's or Master's degree in Pharmacy, Chemistry, or a related scientific field. Demonstrate 15+ years of progressive experience in Quality Assurance within the pharmaceutical industry, with a focus on sterile dosage forms. Exhibit in-depth knowledge of cGMP regulations, ICH guidelines, and global regulatory requirements (US FDA, EU GMP, MHRA, WHO). Proven ability to lead and manage a QA team, fostering a culture of collaboration, accountability, and continuous improvement. Expertise in conducting and managing regulatory inspections and customer audits. Proficiency in Quality Risk Management and the application of QbD principles. Strong problem-solving and decision-making skills, with the ability to analyze complex situations and implement effective solutions.

Production Chemist OSD and Ointment Section Location: Ahmedabad, Gujarat, India Department: Production Job Summary: The Production Chemist will be responsible for overseeing the production processes for oral solid dosage (OSD) and ointment formulations. This includes ensuring adherence to GMP standards, optimizing production efficiency, and maintaining the highest quality of pharmaceutical products. The role involves direct supervision of manufacturing activities, adherence to quality protocols, and collaboration with cross-functional teams to ensure seamless operations. Key Responsibilities: Supervise the manufacturing activities in the OSD and ointment sections, ensuring processes are carried out as per standard operating procedures (SOPs). Ensure compliance with WHO-cGMP, USFDA, and other regulatory standards at all stages of production. Monitor production processes to meet predefined quality, safety, and efficiency goals. Prepare, review, and maintain batch manufacturing records, logbooks, and other production-related documentation. Collaborate with the QA and QC teams to promptly address and resolve quality issues. Train and mentor junior staff and operators on production protocols, equipment handling, and GMP standards. Conduct troubleshooting and maintenance of production equipment and processes to minimize downtime. Assist in the validation of new equipment, processes, and cleaning procedures. Qualifications: Bachelors or Master’s degree in Pharmacy (B.Pharm/M.Pharm). 3-5 years of relevant experience in OSD and ointment production. Strong knowledge of GMP and regulatory guidelines. Proficiency in production planning and execution. Excellent organizational and problem-solving skills. Effective communication and leadership abilities.

Proactively contribute in Project Initiation, execution, Tracking, Monitoring, Troubleshooting and Facilitating activities till dossier filing. Accountable for the overall outcome of the project from Initiation to Completion. Closely work with US, EU, CA, ROW, Brazil Project managers ,Bridge between R&D and different territory Project manager Contribute to Project Initiation in Tool , Project budget preparation. Track and monitor actual vs. budget (cost, man-hours, material) for their optimum utilization To ensure R&D sourcing and Supply chain for API (IH & OSC). RLD, RM/PM, Equipment availability for R&D and Plant, BE studies (CROs) and prioritizing on projects. Provide necessary inputs for initiating the procurement process. Track, review & regulate the progress of the project to meet the deliverables. Compare target, planned and actual (Schedule/cost/quality), report the variance to stakeholders, Identify scope change in cost, schedule, facilitate on necessary approvals. Active participation in Annual Budgeting for R&D, and quarterly reviewing the BE budget of budget vs. actual costing and number of studies. Work closely with Plant TT, Plant QA, and QC for production schedule, monthly, quarterly and annual plans for manufacturing of R&D batches. Track RM release, AMV and TT, Micro validation leading to manufacturing of submission batches at OSD and Sanand. Track deficiency for solid orals and coordinate the priority for different analytical activities leading to deficiency response submission by RA for OSD and Sanand Use of appropriated tools to plan and execute projects from timelines, cost and quality perspective. Conduct timely meetings to keep track of ongoing projects and meet deliverables. PM Initiatives: Contribute in implementation of new initiatives in PM department, Coaching team members on Project Management practices. Planning tracking, monitoring and review of the execution of the batches at manufacturing sites OSD and Sanand, conducting weekly meeting to ensure the smooth functioning and availability of the requirements for batch execution. Compilation of Project closure report on completion of the project, implementation of project management tool for monitoring like variance analysis on timely basis.

Consultant Radiologist Job Name: Consultant Radiologist Job Role: Radiologist Industry:Medical/Health Care Job Location:Jodhpur (Rajasthan) Experience:1to 5Year Salary:Best in The Industry Education:MBBS/MS-OBS Responsibilities: Should be capable of performing ultrasonography. Attend rostered sessions and perform work according to the weekly timetable. Provide clinically appropriate assessment, interpretation and reporting on imaging following accepted professional guidelines. Ensure reports are dictated/transcribed and authorized on a continuing and timely basis. Work with other team members to mutually agreed with work schedules and waiting list management processes, in consultation with the Head of Department / Service Manager. Facilitate access to imaging and provide timely reporting that facilitates efficient patient flows and meets treatment objectives. Utilize resources (investigations options, staff resources and session time) in a rational way within agreed protocols and guidelines. Adhere to the protocols, guidelines and practice standards pertaining to the area of clinical practice. Communicate effectively with and provide advice on inpatients referred by hospital specialist colleagues for assessment, within a timeframe appropriate to the clinical circumstances. Provide verbal advice to GP’s who telephone for assistance. Attend and actively participate in clinical departmental meetings. Will prioritize referrals according to departmental policies, developed under the leadership of the HOD.Vetting of incoming diagnostic referrals for appropriateness using recognized access criteria and suggestion of alternative imaging where relevant. Be available to respond to referrals from the Emergency Department and provide timely turn around of formal radiology reports in accordance with the departmental schedule of responsibilities. Advise the referrer of unexpected incidental findings identified on imaging. Make telephone contact with the referrer to advise of findings that require critical and urgent intervention. The Consultant will adhere to the agreed waiting time criteria for booking of cases. The standards for patient waiting time in clinics will be adhered to. Guidelines for the management of patients in clinics will be adhered to.

Key Responsibilities: Lead and oversee multiple R&D projects, focusing on the development of innovative pharmaceutical formulations, including long-lasting injections and oral dosage forms. Closely interact and work with various cross functional teams like procurement, QC, QA, finance, manufacturing, regulatory affairs, to ensure that project is executed on time. Identify & co-ordinate with suppliers of raw materials, packaging materials, equipment, etc. and external agencies for analysis, preclinical & clinical studies to ensure that project is executed on time. To arrange scale up trials of various dosage forms developed. Preparation of high quality technical documents. To mentor and develop junior scientists and researchers, fostering their growth and enhancing their technical expertise. Foster a culture of innovation and continuous improvement within the R&D team. To collaborate with external partners, CROs, and academic institutions to enhance R&D capabilities and accelerate product development. To represent the Company in scientific conferences, industry forums, and customer meetings, showcasing R&D achievements and capabilities. To provide technical support to business development teams in identifying and evaluating new business opportunities. Candidate profile: Ph.D. / M Pharm in Pharmaceutics with 10+years of experience in formulation R&D.

Roles and Responsibilities: 1. Managing maintenance for OSD utilities, plant equipment, electrical systems, instrumentation, calibration, HVAC, civil design, and overseeing overall site engineering operations, with expertise in handling large volume projects. 2. Evaluate instrument/equipment/calibration points in the SAP system for calibration, preventive maintenance, and breakdown maintenance. 3. Implementing energy conservation strategies for power and fuel cost reduction 4. Achieving optimal plant machinery utilization through the development and implementation of new technologies. 5. Coordinating with corporate engineering for the implementation of utility modification, renovation, and cost reduction projects. 6. Reviewing the maintenance of ASRS and machinery 7. Managing Trackwise, LMS, SAP, Documentum, and EDMS software. 8. Monitoring and maintaining ETP/MEE. 9. Coordinating with government bodies related to Boiler, PCC, DNH Power Distribution Corporation Limited, etc. 10. Implementing cGMP practices, GEP practices, and introducing energy-saving initiatives. 11. Reviewing and approving the investigation, root cause identification, and CAPA derivation for system failures, out-of-specification observations, change control, and action items through the Trackwise (QMS) system. 12. Ensuring compliance with internal audits, external audits, and addressing visit observations. 13. Coordinating with corporate engineering for monthly and quarterly reports. 14. Ensuring compliance with all EHS (Environment, Health, and Safety) requirements 15. Reviewing the operation of EMS/BMS systems. 16. Ensuring vendor services align with AMC schedules. Education : B.Tech (Mechanical) Preferred candidate should have a background exclusively in the Pharma Industry, with specific experience in Oral Solid Facility operations. 2. Preferred candidate should have experience in managing engineering and maintenance activities for a Large Volume block. 3. Desired candidate should possess exposure to GMP Audits Experience : 15 to 18 Years of experience Location : Paonta

Dear Respected All, Greeting from Biophore India pharmaceutical Pvt Ltd. We have opening for Formulation R&D Department - oral solution exp or Injectable Experience : 2-10 Yrs Job Location: Pashamylaram - Patancheruv Job Description: Candidate must have knowledge-Literature Search, Product Development,Scale-up Batches, Characterization, Prototype Development, , Exhibit Batches, DOE Experiments , PDR Preparation & Development related documentation. Experience in US ,EU Markets .Preparation of documents form development stage to Technology Transfer Stage. Preparation and Review of SOP,S related to formulation R&D. Ref to Friends or colleagues Please share me update resume: careers@biophore.com Total Exp : Current C T C : Exp C T C : Notice Period: Current Designation:

Role & responsibilities Conduct literature searches for formulation analytical methods to support method development. Develop, optimize, and validate methods for Assay, RS, GC, PSD, and Dissolution, ensuring regulatory compliance. Troubleshoot and resolve analytical method issues and provide technical guidance for complex analytical challenges. Ensure timely completion of method development and validation activities. Collaborate with cross-functional teams (QC, QA, RA, Formulation Development) for seamless project execution. Ensure smooth execution for all the developmental projects Review and approve FAD documents, including Lab Notebooks, Lab Records, STPs, Specifications, AMV protocols/reports, Method Transfer documents, and Change Control documents. Ensure compliance with regulatory guidelines (ICH, USP, EP, FDA) and maintain high documentation standards. Review qualification and calibration documents of analytical equipment/instruments. Conduct knowledge-sharing sessions to enhance team competencies. Address queries from internal and external customers and regulatory agencies. Identify advancements in analytical technologies and recommend strategic improvements. Participate in continuous improvement initiatives to enhance productivity and efficiency in method development. Review of Standard operating procedures in the Analytical Research and Development (Formulation Analytical Development) and Formulation development. Review of documents from the API Manufacturers, Technology transfer documents and documents from the Contract testing laboratories and Contract manufacturing facilities. Performing assigned tasks by HOD/Designee as and when required as per Organization requirements.

Positions 1) Technology Transfer Scientist (FRD) / 2- 6 years of experience 2) Documentation Lead (FRD)/ 3- 8 years of experience 3) Formulation Development Scientist/ 2- 10 years of experience 4) FRD Injectables / 2- 8 years of experience

Job Responsibilities: Responsible for handling all primary and secondary packaging activities. Monthly and Daily Calibrations of weighing balance and its records Updating of Cleaning Records and Packing Records Labelling of all equipments in Packing Department Checking of all packing activities as per BPR. Ensuring that packing material received from Stores as per BPR Monitoring yield losses during Packing process Coordination with other departments like QA, QC, Production, Stores, Engineering etc. Observation of Good Manufacturing Practices is laid down in packing department. Preparation of production planning (Plan vs Achievements, Maintaining Daily Reports). Handling of manpower & allocation of work at the start of shift / day. Sending requisition for BMR to QA & Dispensing to Warehouse Supervise the packaging activity to ensure maximum productivity. To ensure that proper cleaning, line clearance and operation of equipment during packing line setting. Indenting, issuance, and destruction of stereos and maintaining its record Pedigree 2-5 years of relevant experience in Packing Department in Pharmaceutical Manufacturing Company (Formulations -OSD Only) B.Pharm/M.Pharm/ M.Sc/B.Sc

Walk-in interview For Sun Pharmaceutical Industries Limited, Dadra Date: 30th March 25 (Sunday) We are recruiting for our OSD manufacturing facility located at Dadra Time: 10 AM to 4 PM Interview Venue: Sun Pharmaceutical Industries Ltd, Survey No. 694, Dadra - 396193, (U.T. of D & N. H.), India, Following are the requirements for our manufacturing facility at Dadra Location. 1) Designation: Officer / Sr. Officer / Executive Granulation & Packing Education: B. Pharm / M. Pharm Department: OSD Manufacturing & Packing Experience: 2- 6 years of experience of handling Granulation and Bottle Packing activities in an OSD manufacturing plant, should have knowledge of cGMP. 2) Designation: Technician – Manufacturing & Packing Education: ITI / Diploma/ B. Sc Department: OSD Manufacturing & Packing Experience: 4 - 8 years of work experience in pharmaceutical company, handling Granulation, and Primary & Secondary Bottle Packing activities in a regulated OSD manufacturing plant. 3) Designation: Officer / Sr. Officer / Executive/ Sr. Executive - Microbiology Education: M. Sc / B. Pharm / M. Pharm Department: New Product Quality Control Experience: 2 - 10 years of experience of handling Environment monitoring, MLT Analysis, Culture Maintenance, Media Management & Micro GLP should have knowledge of cGMP. For all the positions, we are looking for candidates with experience in regulated plants like USFDA, MHRA, ANVISA, TGA etc. Interested candidates meeting with criteria should carry their updated resume along with photograph, Photocopy of Salary Supporting/Appointment/latest Increment letters giving salary breakups of Monthly & Annual Salary is must. Those who are unable to attend the personal interview may send their resume by e-mail to rupeshkumar.upadhyay@sunpharma.com

Walkin at Matoda 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. Role & responsibilities QUALITY ASSURANCE IPQA (Injectable) - (Officer / Senior Officer / Executive) Experience - 02 to 08 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. QUALITY ASSURANCE (QMS / Compliance / Documentation/ Validation & Qualification/OSD) (Officer / Senior Officer / Executive/Senior Executive) Experience - 02 to 08 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. Engineering: Instrumentation / QMS (Senior Executive / Executive / Senior Officer) Experience - 03 to 09 Years Qualification BE / B tech with relevant functional experience in Calibration / Instrumentation / QMS activities Injectable - Manufacturing & Packing & Visual Inspection (Senior Executive / Executive / Senior Officer / Officer / Associate) Experience - 01 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma with relevant functional experience in injectable manufacturing/ Aseptic area operations / Packing / Visual inspection / QMS activities OSD Manufacturing & Packing ( Executive / Senior Officer / Officer / Associate) Experience - 01 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / Diploma with relevant functional experience in OSD manufacturing and Packing operations / QMS activities Time and Venue : 29th June 2024, 09:30 Hrs to 15:00 Hrs ______________________________________________________ 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. Preferred candidate profile *Having relevant qualification as mentioned above can attend the scheduled walk-in. Perks and benefits

We have been retained by a highly reputed and fast growing Pharma Company to hire "Senior Manager- QA" to be based at their plant located at Aurangabad. Details of the position are mentioned below: Company: Our client is a highly reputed and fast growing Pharma Company. Company's products enjoy a very high degree of acceptance from doctors within India as well abroad. The company has their manufacturing units spread across different locations in India. The sales turnover of the company is more than 700 Crores. Designation: Senior Manager - Quality Assurance (Formulation Unit manufacturing Oral Solid, Liquid Oral & Sterile Injectables) Educational Qualification: M.Sc. / M. Pharma Experience: Minimum of 10 to 15 years of experience of handling QA function of a reputed Pharma Company. Besides QA, the candidate must have basic understanding of QC function also. The incumbent shall have the experience of working as Deputy Manager / Manager QA or above level in a reputed Pharma Company for at least 3 years Job location: Aurangabad Those of you whose profile matches the above mentioned description and will like to apply for this position shall forward their updated profile to sudhirvinayak@gmail.com In case of a query, please feel free to speak to the undersigned: Sudhir Vinayak Director, Pharma Placements Inc. Mobile: 98202 34987 / 81307 24980

Role & responsibilities Oversee and manage the Quality Control department to ensure efficient laboratory operations. Develop, implement, and maintain QC protocols and Standard Operating Procedures (SOPs) in compliance with GMP, FDA, MHRA, and other regulatory standards. Supervise and mentor QC staff, providing training and technical support to maintain high performance. Conduct routine and non-routine testing of raw materials, intermediates, and finished pharmaceutical products. Ensure timely and accurate analytical testing, stability studies, and method validations. Investigate and resolve out-of-specification (OOS) and out-of-trend (OOT) results, implementing corrective and preventive actions (CAPA). Coordinate with Production, Quality Assurance, and R&D teams to ensure smooth manufacturing and compliance processes. Review and approve analytical data, reports, and COAs (Certificates of Analysis). Ensure proper calibration, validation, and maintenance of laboratory instruments and equipment. Manage laboratory documentation, ensuring compliance with data integrity guidelines. Participate in regulatory inspections, audits, and customer visits, providing necessary documentation and responses. Stay updated on industry trends, regulatory changes, and advancements in analytical techniques. Preferred candidate profile Bachelor's/Masters degree in Pharmacy, Chemistry, Microbiology, or a related field. Minimum 12+ years of experience in Quality Control within the pharmaceutical industry. Strong knowledge of GMP, GLP, ICH guidelines, and regulatory requirements (FDA, MHRA, WHO, etc.). Hands-on experience with analytical techniques such as HPLC, GC, FTIR, UV-Vis Spectrophotometry, etc. Experience in handling QC audits, deviations, OOS investigations, and CAPA implementation.

Experience in pharmaceutical research, experimentation, and data interpretation based on the analytical results . Proficiency in laboratory techniques, handling of equipment’s and GMP knowledge. Good knowledge on the scale-up factors from R D to EB scale. Good formulation development knowledge and passion to become scientist. Knowledge on the pharmacokinetics of drugs is mandatory and proficiency in BE studies is required. Knowledge of regulatory requirements and quality standards in the pharmaceutical industry. Excellent problem-solving, critical thinking, and communication skills

Job Description: Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per EAEU guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Administrative documents requirements (COPP, Mfg. License and Import License) . Registration information management system updates on regular basis.

Hands-on experience in - Perform the Analytical Method Validation by HPLC/GC Preparation and review of AMV Protocol and Reports Operations and calibration of the instruments like HPLC, GC etc. Preferred candidate - Having 5 - 10 yrs of experience in Quality control and must have at least 2 years in AMV

Experience: 2-7years exclusively in Oral Solid Dosage (OSD) production Qualification: ITI/Diploma/B.A/B.Sc Machine Expertise: Fette, Korsch, Kilian, HATA Role: Operate and maintain OSD compression machines efficiently. Apply to: Interested candidates, please send your updated resume to Khaleel.md@granulesindia.com .

Role & responsibilities * Candidate should have minimum 3 years of experience in Production - OSD Formulation handling Granulation / Blending / Compression / Coating / Packing etc. * Should have machines operating experience & trouble shooting experience. * Should have BMR / BPR Preparation and online documentation experience. * Should be from USFDA approved plant only. Perks and benefits Best in the industry.

Job Summary: Walter Bushnell is seeking a Research Associate Formulation with experience in Solid Oral Products to join our R&D team . The candidate will be responsible for formulation development, process optimization, and ensuring regulatory compliance for solid dosage forms. Key Responsibilities: Develop and optimize formulations for solid oral dosage forms (tablets, capsules, granules, etc.). Conduct pre-formulation studies, excipient compatibility tests, and stability studies . Perform process development, scale-up, and technology transfer for new formulations. Prepare and maintain technical documentation, protocols, and reports as per regulatory guidelines. Ensure compliance with cGMP, ICH, and regulatory standards for formulation development. Collaborate with analytical, regulatory, and manufacturing teams for successful product development. Troubleshoot formulation and process-related challenges to improve product stability and quality. Qualifications & Skills: Education: M. Pharm / B. Pharm in Pharmaceutics or related field. Experience: 4-5 years in formulation development of solid oral products . Strong knowledge of cGMP, ICH guidelines, and regulatory requirements . Hands-on experience in process optimization, scale-up, and tech transfer . Proficiency in documentation and regulatory compliance . How to Apply: Interested candidates can share their resumes at akanksha.jaiswal@walterbushnell.com . For further details, you can directly reach out at 7042636289 .

Job Title: Production Supervisor Job Location: Bangalore About Syngene : Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit. Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to companys integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role: Should have expertise in granulation, compression, and coating area is mandatory. The candidate should have 5 to 9 years of experience in any pharmaceutical organization and the qualification should be Bachelor or post-graduate in pharmacy. The handling of machine setup, troubleshooting, operation, change over, and cleaning of manufacturing equipments like FBP, RMG, Roller Compacter, Fluid bed Wurster granulator/coater, tablet compression and tablet coating machine are the key requirements. Should handle the IQQC instruments like Halogen moisture analyser, Tap density apparatus, sieve shaker, Hardness tester etc. Should have good knowledge of data integrity concept (ALCOA+), GDP and cGMP norms. Should have good communication skills. He should have experience of audit handling. Should have a good knowledge of housekeeping, area maintaining as per client visit, internal and external audits. Role Accountabilities: The person will be accountable for monitoring of Production activity, the primary role and responsibility will be closely involvement in all manufacturing activities, area maintaining as per audit requirement. Also, will be involved in internal and external client visits and audits. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Experience: 5 to 9 years Skills and Capabilities: Should expertise in granulation, compression, and coating area is mandatory The handling of machine setup, troubleshooting, operation, change over, and cleaning of manufacturing equipment’s like FBP, RMG, Roller Compacter, Fluid bed Wurster granulator/coater, tablet compression and tablet coating machine are the key requirements. Should handle the IQQC instruments like Halogen moisture analyser, Tap density apparatus, sieve shaker, Hardness tester etc. Education: Qualification should be Bachelor or post-graduate in pharmacy Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

We are seeking an experienced Head in the Quality Assurance department to oversee and ensure the highest level of quality standards across our organization. The ideal candidate will have at least 15 years of experience in quality assurance, with a proven track record of managing and leading a team. 1. Quality Management System (QMS) Oversight Develop, implement, and maintain the Quality Management System in compliance with local and international regulations (e.g., CDSCO, WHO, USFDA, MHRA). Conduct regular reviews and updates of QA policies and procedures. 2. Regulatory Compliance Ensure all manufacturing processes and documentation comply with regulatory requirements. Prepare for and manage regulatory inspections and audits. Liaise with regulatory bodies and ensure timely submission of required documentation. 3. Product Quality Assurance Oversee all aspects of quality control for OSD formulations, including raw materials, in-process controls, and finished products. Approve or reject raw materials, intermediates, and finished products based on quality standards. 4. Quality Control (QC) Coordination Collaborate closely with the QC department to ensure proper testing of materials and products. Review and approve QC reports and ensure timely release of products. 5. Deviations and Investigations Lead investigations into quality incidents, deviations, or non-conformances. Implement corrective and preventive actions (CAPA) to prevent recurrence. 6. Documentation and Record Keeping Ensure proper documentation practices (GDP) are followed. Review and approve Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and other critical documents. 7. Training and Development Conduct training programs for QA and plant staff on quality standards, regulations, and best practices. Foster a culture of continuous improvement and compliance. 8. Supplier and Vendor Management Approve and audit suppliers and vendors to ensure the quality of raw materials and services. Ensure supplier compliance with quality agreements and standards. 9. Risk Management Identify, assess, and mitigate risks associated with product quality. Conduct risk assessments and implement control measures as necessary. 10. Cross-functional Collaboration Work closely with production, RD, and other departments to ensure quality is integrated into all processes. Provide QA support during product development and technology transfer. 11. Continuous Improvement Drive continuous improvement initiatives to enhance product quality and operational efficiency. Monitor industry trends and update practices accordingly. 12. Ethical and Safety Compliance Ensure all QA activities are conducted ethically and with a focus on employee and consumer safety. Promote a safe working environment and adherence to health and safety regulations. This role demands strong leadership, excellent communication skills, and a deep understanding of pharmaceutical quality standards and regulatory requirements Preferred candidate profile Head- Quality Assurance in EU approved OSD Pharma Plant Perks and benefits Company Family Accommodation will be provided Personal Mediclaim and Accident Insurance upto Rs 5 lakhs

Company: Strides Pharma Department: IPQA Profile: - Executive Office Locations: Alathur Qualification – B. Pharmacy/ M. Pharmacy Experience – 2 to 6 years (Must have exposure to OSD) Job Description: • To perform IPQA activities at shop floor in each and every stage of sterile manufacturing and packing. • QA overview for clean room behaviour and aseptic activity. • Review of batch processing records. • Review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release. • Review of documents of respective areas and logbooks for adequacy and completeness. • QA overview for receipt of material from warehouse to production. • IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities. • Review and Control of SOP’s, Specification, BPR issuance, Master Formulae and Records. • Preparation & Review of process validation protocols and reports. • Executing the validation/revalidation activity in the absence of authorized person. • Any job activity assigned by HOD • Responsible for regulatory audits with exposure equivalent to WHO Geneva PQ/USFDA Competencies: • Execute IPQA Excellence by setting clear benchmarks. • Smart Thinker and displays smart/ tactical moves & mental agility. • Is open and flexible when faced with changing circumstances and finds ways and means of doing things and not get struck with the past. • Comes up with ideas which are different and can be used commercially, profitably and growth. • Support and guide subordinates by giving appropriate examples & feedback. Encourage team to come up with new ideas. • Proposes solution which has elements of sustainability.