40 Who Jobs - Page 2

Job Description: Manager / Senior Manager - Quality Control To lead quality control activities in our API /Bulk Drug manufacturing facility in Humnabad. The role involves ensuring that all products meet GMP, WHO, FDA, and other regulatory standards, conducting quality testing, and managing a team of QC professionals. Key Responsibilities: - Oversee quality control processes for raw materials, in-process, and finished products. - Ensure compliance with GMP, WHO, USFDA, and local regulatory requirements. - Conduct laboratory testing, validation, and stability studies. - Handle internal and external audits, inspections, and regulatory documentation. - Investigate quality deviations, implement CAPA (Corrective and Preventive Actions). - Train and supervise QC staff to maintain high-quality standards. - Stay updated with latest pharmaceutical quality trends and compliance norms. Requirements: - B.Pharm/M.Pharm, M.Sc. (Chemistry), or related qualification. - Minimum Experience 18 20 years in QC (API & Bulk Drugs). - Strong knowledge of analytical techniques (HPLC, GC, UV, etc.). - Hands-on experience with GMP, ICH guidelines, and regulatory audits (USFDA, MHRA, etc.). - Excellent leadership, problem-solving, and documentation skills

Job Summary: The Microbiologist will be responsible for ensuring microbiological quality assurance and compliance in pharmaceutical manufacturing processes. The role includes conducting microbiological testing, validation, and ensuring compliance with WHO-cGMP and other global regulatory standards. Location: Ahmedabad (Kalol)- Local candidates preferred Key Responsibilities: Perform microbiological testing of raw materials, finished products, and water. Conduct sterility, bioburden, and endotoxin testing. Oversee environmental monitoring of cleanrooms. Validate microbiological methods and equipment. Prepare and review microbiological reports and documentation. Implement and maintain microbiological controls in line with regulatory standards (USFDA/EU/PIC/S). Investigate microbiological deviations and provide corrective actions. Qualifications & Skills: Bachelors/Masters in Microbiology or related field. 4-6 years of experience in pharmaceutical microbiology. Strong knowledge of WHO-cGMP standards and regulatory guidelines. Excellent analytical and problem-solving skills.

Expertise in ROW market, understanding nuances in regulatory demands across regions in-depth knowledge of FDA Guidelines to ensure compliance in documentation and submissions. Proficiency in handling technical documents to facilitate accurate and timely submissions Proven ability to review regulatory documents and submissions effectively, ensuring their accuracy and compliance Strong analytical skills to assess regulatory data and provide critical insights for decision-making Experience in dossier preparation, organizing comprehensive documents for regulatory authorities Attention to detail to meticulously handle documentation and regulatory records Excellent communication skills to liaise with regulatory agencies and internal departments Preparation of registration dossiers as pe regulatory guidelines Preparation of renewal application as per renewal guidelines Facilitate query response raised by regulatory authority and customers Preparation and submission of Safety, Quality & administrative variations as per variation guidelines

Working with Us Challenging Meaningful Life-changing Those aren't words that are usually associated with a job But working at Bristol Myers Squibb is anything but usual Here, uniquely interesting work happens every day, in every department From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity Take your career farther than you thought possible Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives Read more: careers bms com/working-with-us Collaborate with clinical stakeholders to understand their reporting and analytics needs aligned with study protocols May Translate requirements into comprehensive reporting development specifications, in collaboration with Report end users Support for utilizing existing standard reports whenever possible and to suggest solutions as needed for any new additional requirements Develop reports and analytics visualizations according to specified requirements, ensuring a "first time right" approach Test developed reports, document results, and provide peer review support as needed Adhere to documentation and process compliance, notifying management of any noncompliance Knowledge of regulatory requirements such as ICH, FDA 21 CFR part 11 and GxP Work cohesively with team members, embracing feedback and suggestions Keeping up to date with new reporting tools, techniques, and industry trends to enhance skills and knowledge Plan for your day, make a to-do list and prioritize your tasks based on clinical study needs and consult Line managers for support Embrace feedback and suggestions, continuously working to enhance knowledge and professionalism in the work environment Participate in departmental/organizational activities/initiatives at the site level to build contacts across the organization, fostering collaboration for the benefit of patients Flexible to work with global stakeholders across different time zones while ensuring business continuity as needed If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway You could be one step away from work that will transform your life and career Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues On-site Protocol Responsibilities BMS has a diverse occupancy structure that determines where an employee is required to conduct their work This structure includes site-essential, site-by-design, field-based and remote-by-design jobs The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms com Visit careers bms com/ eeo -accessibility to access our complete Equal Employment Opportunity statement BMS cares about your well-being and the well-being of our staff, customers, patients, and communities As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers bms com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations

Job purpose The Manager/ Sr. Manager of Pharmacovigilance will navigate the complex landscape of clinical safety, on all aspects of clinical safety throughout the entire lifecycle of a product with special emphasis on ongoing evaluation of safety information during clinical development and state of the art pharmacovigilance post approval. This role reports directly to the Chief Medical Officer at Ocugen. Duties and responsibilities As the Manager/ Sr. Manager of Pharmacovigilance, Clinical Quality, Safety and Pharmacovigilance, you will be tasked with applying sound judgment for the analysis and interpretation of complex clinical safety data for signal detection and initiation of safety risk management activities including safety specification, PV planning and risk minimization/mitigation. The role will require the identification and implementation of all clinical standard-operating procedures in order to ensure GCP compliance. The role serves as the senior clinical safety representative in the cross-functional development teams. You will be responsible for setting Ocugens clinical safety strategy for these global projects. The role identifies potential challenges, risks and roadblocks associated with the global safety domain and works as a leader in developing solutions to address these. The role ensures that the medical and process standards delivered at Ocugen are in alignment with following safety objectives expected of manufacturers by internal and external stakeholders including regulators, governmental agencies, payors, physicians, patients, and the general public. Responsibilities include overseeing the safety signal detection and medical signal evaluation process and analysis of aggregate safety data and the production of key company documents such as DSURs (Development Safety Update Reports), PSURs (Periodic Safety Update Reports) and risk management plans relating to the safety of medicinal products, which are subject to regulatory review and discussion. Providing a safety role in facilitating reviews done by internal and external DMCs (Data Monitoring Committees) and in unblinding clinical data to protect ongoing study participants and complete timely communications to Health Authorities Ensures timely production of aggregate reports and answers to queries from Health Authorities according to consistent quality standards. Participate actively in the Continuous Improvement Process (CIP) targeted at continuous improvements of quality of processes, methods, and communication. Review and contribute to safety relevant SOP and improvement of safety relevant SOPs. Responsible for timely and concise responses to Regulatory Agency requests relating to patient safety. Ensures regulatory agency inspection findings and internal audit findings relating to products of responsibility are addressed and resultant Corrective Action Plans (CAPA plans) are implemented efficiently and effectively in the function. Set safety strategy based on strong product knowledge and biologicals safety experience that allows for successful IND (Investigational New Drug)/NDA (New Drug Application) filings and initiation of first in human studies. Oversees all processes that lead to the production of safety sections and content of relevant clinical trial documents including protocols, investigator brochures, informed consent forms, clinical study reports. Oversees development of core safety information for new products Provides major contributions to current and potential safety issues, being proactive in addressing safety issues and setting up any additional systems to mitigate risk in Ocugen’s studies. Gives guidance on various medical, product-related and process-related matters in a complex medical and scientific environment including many interface departments and functions. Complies with legal requirements and company standards of the PV (Pharmacovigilance) tasks and responsibilities: Preventing harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of the market authorization or from occupational exposure Promoting the safe and effective use of medicinal products through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public Contributing to the protection of patients and public health The role identifies tools necessary to facilitate safety surveillance and clinical safety assessment and to implement necessary risk management initiatives. Provides input into clinical development, due diligence, regulatory and issue management activities from a clinical safety perspective and represents the position of GCSP in internal governance committees and in discussions with Health Authorities Qualifications Eight(8) to Thirteen (13) years pharmaceutical/biotechnology industry experience, of which at least six (6) should be in a safety role, with broad overview of all aspects of a PV system and specific experience in signal detection and risk management. Experience and success in addressing and managing complex safety issues in the pre-approval and post-approval environment including interfacing with external regulatory bodies (written and verbal interactions. e.g. External Audits, Ad Coms, CHMP Oral Explanations, etc.) Knowledge of scientific data relevant to own products and across therapeutic area, including the competitive environment and the disease state Strong understanding of data capture, data management and statistical methods for the preparation and analysis of safety data in clinical trials Detail oriented, exceptional documentation practices, technical writing, and verbal communication skills. Ability to convey complex concepts through clear and concise messages. Excellent problem-solving skills, contingency planning, and risk-mitigation strategies Ability to navigate and be successful in a fast-paced, highly matrixed work environment. Working conditions This position operates in an office setting and may include 20% of travel from time to time. Physical requirements This is a largely sedentary role.

Job Description Company: GreenSignal Bio Pharma Pvt Ltd Location: Gummidipoondi, Chennai, Tamil Nadu Experience: 1-12 years above in production, preferably in the Bio-Pharmaceutical industry, specifically in vaccine manufacturing Educational Qualification: MSc Microbiology/Biotechnology/B. Pharm/B.Tech with more than 8 years of experience in vaccine biologicals and injectables Job Title: Senior Manager / Manager / Executive- Production Job Summary: The Senior Manager /Executive - Production will oversee daily vaccine manufacturing operations, ensure compliance with regulatory guidelines, manage production staff, and drive continuous improvement to enhance operational efficiency and product quality within the pharmaceutical industry. Key Responsibilities: Production Planning and Coordination: Plan, coordinate, and optimize end-to-end vaccine production activities to meet quality standards, timelines, and cost targets while ensuring resource availability. Oversee Manufacturing Operations: Supervise day-to-day manufacturing operations, including formulation, filling, packaging, and storage processes, ensuring efficient workflow and compliance with production protocols. Compliance: Ensure adherence to Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), and regulatory guidelines (FDA, EMA, WHO). Issue Resolution: Troubleshoot and resolve production-related issues to minimize downtime and ensure batch integrity. Team Management: Lead and manage production staff, providing training on safety, quality, and operational protocols specific to vaccine manufacturing. Performance Monitoring: Track key production metrics, implement strategies to improve batch yields, and reduce material wastage. Safety Enforcement: Enforce workplace safety protocols to prevent accidents, contamination, and ensure bio-safety compliance. Risk Management: Identify risks in production processes, such as contamination risks or equipment failures, and develop contingency plans. Material Handling: Ensure safe handling, storage, and disposal of biological materials, vaccines, and hazardous chemicals following industry best practices. Process Improvement: Drive continuous improvement initiatives to enhance production efficiency and product quality. Equipment Management: Oversee the maintenance, calibration, and validation of production equipment to ensure optimal performance. Documentation and Reporting: Ensure accurate documentation of production activities and prepare reports for regulatory compliance and internal audits. Skills and Competencies: Strong leadership and team management abilities in vaccine manufacturing environments In-depth knowledge of GMP, regulatory compliance, and vaccine production protocols Proficient in production planning, batch processing, and process optimization Excellent problem-solving and troubleshooting skills within pharmaceutical production settings Strong communication and interpersonal skills for effective team coordination Risk assessment and mitigation capabilities specific to biological production Commitment to bio-safety, product quality, and continuous improvement About GreenSignal Bio Pharma Pvt Ltd: GreenSignal Bio Pharma Pvt Ltd is a leading pharmaceutical company dedicated to delivering quality healthcare solutions, with a strong focus on vaccine manufacturing and biological products. Our commitment to innovation, compliance, and operational excellence drives our success. For more information, please visit our website: www.gsbpl.com How to Apply: Interested candidates can apply at: hr@gsbpl.com Contact us at: 8778926365 Apply Now to join our team and contribute to impactful pharmaceutical and vaccine innovations!

Job Title: Executive / Manager/Senior Manager Quality Control Department: Quality Control (QC) Company: Greensignal Bio Pharma Pvt Ltd Location: Gummidipoondi, SIPCOT, Chennai Position Overview: The Manager/Senior Manager of Quality Control (QC) at Greensignal Bio Pharma Pvt Ltd is responsible for developing, implementing, and managing quality control strategies and activities. This role ensures that all quality control processes are compliant with industry regulations and align with organizational goals. The individual will lead various quality control activities, such as sampling, testing, inspection, and documentation, while ensuring compliance with regulatory standards. Key Responsibilities: Develop and implement quality control strategies that align with organizational goals and regulatory standards (e.g., FDA, EU, WHO). Collaborate with cross-functional teams to ensure alignment of quality control objectives across departments. Oversee quality control activities, including sampling, testing, inspection, and documentation, ensuring compliance with internal and external standards. Ensure all quality control activities meet required regulatory standards (e.g., FDA, EU, WHO), and implement corrective actions when needed. Develop, maintain, and review quality control procedures, policies, and documentation to ensure consistency and compliance. Conduct internal audits to evaluate compliance with quality control procedures and identify areas for improvement. Collaborate with the regulatory affairs team to ensure timely and accurate submission of quality control documentation for regulatory filings. Provide training, guidance, and coaching to team members, ensuring they possess the necessary skills to perform quality control tasks effectively. Communicate quality control results, non-conformances, and corrective actions to cross-functional teams in a timely manner. Identify opportunities for continuous improvement in quality control processes and implement initiatives to improve efficiency and compliance. Minimal Qualifications: Education: Masters degree in Microbiology, Life Sciences, Pharmacy, or a related field (M.Sc. Microbiology preferred). Experience: Minimum of 8 years of experience in quality control, preferably in the pharmaceutical or biotechnology industry. Knowledge: Strong understanding of regulatory requirements (e.g., FDA, EU, WHO), microbiology, instrumentation, EMP, failure investigation, and related documentation. Skills: Excellent leadership and project management abilities. Strong written and verbal communication skills. Ability to collaborate effectively with cross-functional teams. Preferred Qualifications: Experience with global regulatory filings and compliance audits. Certification in Quality Management Systems (e.g., ISO 9001, Six Sigma). Expertise in advanced microbiological testing techniques. Personal Attributes: Strong problem-solving skills with keen attention to detail. Proactive and able to thrive in a fast-paced, dynamic environment. Ability to motivate, inspire, and develop team members. To Apply: Please submit your resume and cover letter detailing your qualifications and experience to the following contact details: Email: hr@gsbpl.com Mobile: 8778926365

Hello Candidate, Greetings from Hungry Bird IT Consulting Services Pvt Ltd. We are hiring Production Manager - API Manufacturing for our client a leading pharmaceutical manufacturing company dedicated to API/Intermediate. Company: Leading Pharmaceutical API Production Company Location: 1) Hyderabad, 2) Visakhapatnam About the Company: Active Pharmaceutical Ingredient manufacturing company, robust product portfolio spread over major product segments encompassing Expectorants, Muscle Relaxants, Analgesic and Anti Fungal. Job Description We are seeking a highly skilled and experienced Production Manager to oversee the production operations of our Active Pharmaceutical Ingredient (API) manufacturing facility. The ideal candidate will have a deep understanding of API manufacturing processes, particularly in the areas of expectorants, muscle relaxants, analgesics, and anti-fungal APIs. Key Responsibilities: Production Planning and Scheduling: Develop and implement comprehensive production plans and schedules to meet customer demands and optimize resource utilization. Monitor production progress and adjust plans as needed to ensure timely delivery. Process Optimization: Continuously evaluate and improve existing production processes to enhance efficiency, reduce costs, and improve product quality. Implement innovative technologies and techniques to optimize production yields and minimize waste. Quality Assurance: Ensure strict adherence to cGMP, ISO, and other relevant regulatory standards. Oversee quality control procedures, including sampling, testing, and documentation. Collaborate with the Quality Assurance team to identify and resolve quality issues promptly. Team Management: Lead and motivate a team of production personnel to achieve production goals. Provide training and development opportunities to enhance employee skills and knowledge. Foster a positive and collaborative work environment. Regulatory Compliance: Stay updated on regulatory requirements and industry best practices. Ensure compliance with all applicable regulations, including FDA, EDQM, and WHO guidelines. Prepare and submit regulatory documentation as required. Safety and Environmental Compliance: Implement and enforce strict safety protocols to minimize workplace accidents and injuries. Promote a culture of safety and environmental responsibility. Ensure compliance with environmental regulations and waste management guidelines. Troubleshooting and Problem-Solving: Identify and troubleshoot production issues, such as equipment malfunctions, process deviations, or quality problems. Implement effective solutions to minimize downtime and maximize productivity. Qualifications and Experience: Bachelor's or Master's degree in Pharmacy, Chemical Engineering, or a related field. Minimum of 10 years of experience in API manufacturing, with a strong focus on expectorants, muscle relaxants, analgesics, and anti-fungal APIs. In-depth knowledge of API manufacturing processes, including synthesis, purification, and formulation. Strong understanding of cGMP, ISO, and other regulatory requirements. Proven track record of leading and managing production teams. Excellent problem-solving, decision-making, and analytical skills. Strong communication and interpersonal skills. Ability to work under pressure and meet tight deadlines. If you are a highly motivated and experienced Production Manager with a passion for API manufacturing, we encourage you to apply. (Interested candidates can share their CV to krishna@hungrybird.in or call on 9966952299.) Please furnish the below-mentioned details that would help us expedite the process. PLEASE MENTION THE RELEVANT POSITION IN THE SUBJECT LINE OF THE EMAIL. Example: KRISHNA, HR MANAGER, 7 YEARS, 20 DAYS NOTICE Name: Position applying for: Total experience: Relevant Experience: Notice period: Current Salary: Expected Salary: Thanks and Regards Krishna +91 9966952299

Role & responsibilities Responsible for Drup Product Manufacturing Ensure compliance to Current Good Manufacturing Practices (cGMP)& documentation thereof for various production activities. Filling line in built CIP, SIP operations Knowledge of Isolator VHP, Blending vessels- CIP, SIP Good at QMS Regulatory inspection exposure WHO-PQ, USFDA, EU GMP, TGA,ROW Experience in O RABS, Isolator filling lines Lyophilizers - ALUS, Manual operations Blending of viral, bacterial vaccines Media fill activities , TRS 1044 updates Responsible for preparing production plan in consultation with PPIC department and execution thereof with effective planning and utilization of Men, Materials and Machineries for quality linked productivity. To approve the instructions relating to production operations and to ensure their strict implementation. To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality. To ensure that the production records are evaluated and signed by an authorized person. Review investigation of Quality Management System (QMS) including market complaint, Out of Specification (OOS), change controls of manufacturing, risk assessment, Corrective Action and Preventive Action (CAPA) etc. To ensure the qualification and maintenance of department, premises and equipment. Ensure compliance to master formula and process provided in the Batch Manufacturing Record (BMR). To ensure that the appropriate validations are done. Reviewing document like of Standard Operating Procedures (SOPs), Batch Manufacturing Record (BMR), Batch Packing Record (BPR), Master Formula Record (MFR)etc. and compliance reports thereof with training of personnel on the same. Ensure appropriate inventory of Consumable in the Department for smooth functioning. Responsible for Co-ordination with Technical Services, Quality Assurance / Quality Control, Finance, Purchase, Warehouse and Administration Departments for effective management of Production targets. Ensure wastage control and optimization of yield at various stages of manufacturing and packaging operations. Ensure compliance to various In-process control guidelines provided in the batch documents. Ensure periodic preventive maintenance of plant and machineries as per schedule worked out by Engineering for optimum performance. Ensure that personnel follow basic safety guidelines during operations. Responsible for the preparation of training calendar for employees and to ensure that the required initial and continuing training of department personnel is carried out and adapted according to need on cGMP and various operational activities. Responsible for preparation of accurate and timely reports of various production activities showing performance and shortcomings against agreed/planned parameters (monthly presentation, work in progress (WIP) statement yield report, monthly planning, expense budget stationary, housekeeping material, production item &capital budget etc). Preferred candidate profile M.Pharm/ B.Pharm / MSc ; Experience- 18 to 25 years Candidate Must have exposure of regulatory Audits should be willing to relocate with family to ahmedabad

Renavo Technologies is looking for Content Writer Conducting in-depth research on industry-related topics in order to develop original content. Developing content for blogs, articles, product descriptions, social media, and the company website. Assisting the marketing team in developing content for advertising campaigns. Proofreading content for errors and inconsistencies. Editing and polishing existing content to improve readability. Conducting keyword research and using SEO best practices to increase traffic to the company website. Creating compelling headlines and body copy that will capture the attention of the target audience. Identifying customers’ needs and recommending new content to address gaps in the company's current content.

Desired Experience : 3-7 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Main purpose of the Job: Responsible for Preparation of Regulatory Documents for submission to Indian NRA, WHO and other Regulatory Authorities. Job Responsibilities: 1. Preparation of following Regulatory Submission Packages related to NRA submissions but not limited to. a. Application for Post Approval Change(s) b. Marketing Authorization Applications c. Clinical trial applications d. Support the submission of Import licenses/ export NoC e. Support the preparation, review and submission of applications/ response to RCGM vide IBSC f. Support in handling of SUGAM, IBKP, NSWS & ONDLS/ ODLS sites 2. Assisting in Responding Queries to various regulatory authorities. 3. Preparation of dossiers / submission packages for NRA submissions. 4. Preparation of dossiers for registration in ROW countries. 5. Maintenance of Documentation Data base available with RA. 6. Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution and Marketing. 7. Routine Interaction with QA-documentation for updating Master Files. 8. Review of Pack Profiles. 9. Review of Artworks (Labels and Package Insert). 10. Preparation / compilation of technical documents related to tenders / queries. 11. Arranging Samples required for registration. 12. Any other support required by the other members of RA. Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for Department Name

In-Process Quality Assurance During Production Activity Including Line Clearance And Sampling At Different Stages Of Processing/Packing As Per Pharma API Review of Master Documents such As BMR / BPR Test Batch Monitoring Process Validation Protocol Required Candidate profile Experience with reputed API or Bulk Drugs Unit Co-Ordinate with Plant QA And RA for PDR related activities To Review Specification, MOA And Analytical Data Good Computer And Communication skill Etc

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

* Experience of GC -HPLC & all Lab INSTRUMENTS. * Documentary work, SOP preparation & Handling all Lab activity. * ISO, GMP, FDA, WHO Audit Faced * Having an instrumental and wet lab. Required Candidate profile * Implement & monitor good documentation practices to ensure data traceability. * Investigate customer complaints related to API quality and coordinate corrective & preventive actions (CAPA).