20 Qualification Jobs

Role & responsibilities protocol Preparation, review and execution for plant qualification preparation of process validation protocol, preparation and compilation of validation report co-ordinate for 3rd party calibration risk assessment preparation annual product review QMS, Change control, DEviation Preferred candidate profile B.Pharma/M.Sc with minimum 6-8 yrs experience in QA. candidate must have exposure of working in regulatory pharma plant.

We are hiring for a Green Field Projects at Amneal , Ahmedabad. Following is the JD : Key Responsibilities : Lead QA operations related to Qualification & Validation, including Cleaning Validation, Process Performance Qualification (PPQ), and Computer System Validation (CSV). Develop and implement Validation Master Plans (VMP), Contamination Control Strategies, and Quality Risk Management (QRM) frameworks. Ensure qualification and validation of manufacturing equipment, utilities, and computerized systems to meet regulatory requirements. Drive regulatory inspection readiness, acting as SME for audits including USFDA, EMA, ANVISA, and WHO. Implement and optimize QMS using a risk-based approach, ensuring continuous monitoring and integration of compliance standards. Oversee execution of large-scale validation projects, such as Green Field Injectable facilities, and ensure regulatory approval readiness. Collaborate cross-functionally with Quality, Engineering, Production, and Regulatory Affairs teams for the successful and timely delivery of validation-related initiatives. Promote lean validation practices and continuous improvement strategies to enhance operational efficiency and regulatory compliance. Mentor, develop, and manage a high-performing QA validation team in a cross-cultural, fast-paced environment. Key Requirements : Education : Bachelors or Masters degree in Pharmacy, Chemistry, or related life sciences field. Experience : Minimum 15 years of experience in QA with strong specialization in Qualification & Validation within pharmaceutical manufacturing. Proven experience in injectable/sterile manufacturing environments is highly desirable. Hands-on experience in handling international regulatory audits and validations across FDA, EMA, and ANVISA-regulated markets. Technical Skills : Expertise in Cleaning Validation, PPQ, CSV, QRM, and VMP development. Strong command of GxP and global regulatory guidelines. Proficient in developing and managing QMS with focus on compliance and risk management. Leadership Skills : Demonstrated ability to lead cross-functional teams, influence stakeholders, and manage complex projects under tight timelines. Strong communication, decision-making, and coaching capabilities. Preferred Attributes : Green Field project experience, especially in injectables. Recognized as an SME in QA Validation. Familiarity with modern digital QA tools or systems is an added advantage. Interested candidate can share CV at bhuvneshwari.rathore@amneal.com

External Job Description Job title: Qualification & Validation Expert, Report Issuance Location: Hyderabad About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Main responsibilities: Apply and align documentation standards with global quality team. Ensure that qualification reports and activities adhere to all applicable quality regulations and pharmaceutical practices. Validate that qualification activities meet health-related requirements, including safety and environmental standards. Review qualification protocols, reports, and documentation for accuracy, completeness, and compliance. Collaborate with cross-functional teams, including Quality Assurance, and Engineering, to ensure alignment and consistency in qualification practices. Provide training and support to team members on compliance-related topics and best practices. About you: Experience: >5 years professional experience in qualification Soft skills: Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments Technical skills: Quality systems (e.g., Veeva, Kneat), Word, Excel, Power Point Education: Bachelors degree in engineering, Pharmacy, Chemistry, or a related field. Advanced degree (e.g., MSc, PhD) preferred Languages: Excellent English communication and writing, French or other Languages in addition preferred.

Qualification & Validation Specialist, Report Issuance Location: Hyderabad About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Main responsibilities: Include references to relevant documents essential for the qualification process. Finalize qualification protocols and reports by adjusting layout and format to meet organizational standards and regulatory requirements Communicate the approval of qualification protocols and updates to all relevant stakeholders via Content Management Systems (CMS), ensure timely dissemination of information and update. Schedule formal consolidated review and approval meetings for qualification protocols Launch and manage the review workflow in CMS, tracking progress and ensuring deadlines are met. Collaborate closely with the Global Qualification Team Lead, Expert, and Specialist to support qualification activities Ensure all documentation complies with overall documentation standards. Identify opportunities for process improvement in document management and workflow efficiency and implement enhancements to streamline qualification protocol finalization and communication processes About you: Experience: Professional experience in general documentation and project management. Soft skills: Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments. Technical skills: CMS, Quality systems (e.g., Veeva, Kneat), Word, Excel, Power Point. Education: Bachelors degree in business administration, life sciences, or a related field. Languages: Excellent English communication and writing, French or other Languages in addition preferred

Role & responsibilities 1.Machinery Breakdown Management. 2. Operation and Preventive Maintenance. 3. SOP Preparation and Documentation. 4.Training and Development. 5.Equipment Qualifications. 6.Documentation and Data Management. 7.Material Coordination. Description: Attend or delegate personnel to attend machinery breakdowns promptly Monitor and verify the operation, preventive maintenance, and troubleshooting of process equipment. Responsible for qualifications (IQ, OQ, PQ), requalification, and revalidations of process equipment.

Preparation& Review of stability study protocols,reports, summery sheet for all the products ( General Injectable &OSD) cross functional with R &D,QA,Prodcution etc. ,GMP/SOP training QC Activities ADL/Oncology & General Block Qualification/issuance

Designation Senior Associate CQV (Quality Assurance) Department Quality Assurance Experience 5+Years Job Location Bangalore 4+ years of experience in FDA-regulated industry Knowledge of pharmaceutical laboratory and process systems; Experience with Biologics equipment preferred Job Responsibilities: Take charge as Single Point of Contact for site validation/qualification (Equipment & Facilities) requirements. Responsible for scheduling, planning and ensuring execution of qualification/requalification (equipment, facility HVAC, Water system, Gases qualification) related to facility. Prepare and review of qualification / requalification protocols and reports. Perform thermal mapping activities for equipment available at site using Kaye Advanced Validator System. Draft and review of SOPs related to validation, Commissioning & Qualification. To manage change control, deviations, CAPAs, risk assessments related to Facilities & Equipment. To provide initial and regular training to team and other department personnel SOPs & protocols related to Validation, qualification/ requalification. Handling and maintenance of validation accessories & managing inventory. Identify and qualify service provider for validation services providers. Participate in External Service Provider (Engineering services) audits. Preparation of project & validation plan for facility expansion, capacity enhancement project. Take lead as Validation In-charge for new equipment & facility commissioning.

Hands on experience IPQA activities for OSD (Tablets & Capsules) Experience in qualification activitie s for all equipments, instruments, utility and facility. Experience in handling of QMS activities, Change control management, OOS/OOT/Deviation/incidents & Market complaint investigations. Experience in preparation & review of MFR/ SOPs/Protocol/Reports etc., Experts in Line clearance, Audi t trail checks, BMR & BPR Review. Experience in Analytical data review /Audit trail review, analytical QA functional activities. Hands on experience handling of self-inspection , regulatory inspection & customer audits . Experience in handling of Trainings activities and training co-ordination. Experience handling of vendor management, Supplier & service provider qualification. Experience in document management & control.

Overall responsible for all type qualification and validation activity. Overall responsible for review of documents, calibration/ validation/qualification activities. Overall responsible for Inprocess Quality Assurance, TTD / PDR review / process review. Overall responsible for Vendor Qualification / vendor questionnaire/ Material management

Roles and Responsibilities Review loan applications to determine creditworthiness of borrowers. Analyze financial statements, tax returns, and other relevant documents to assess borrower's credit risk. Conduct thorough analysis of applicant's financial situation using various tools such as DTI ratios, FICO scores, etc. Verify income documentation through employment verification calls or third-party vendors. Make informed decisions on approving or denying loans based on risk assessment. Desired Candidate Profile 1-6 years of experience in mortgage underwriting with a focus on conventional loans (FHA & VA). Strong understanding of US residential mortgage industry regulations and guidelines. Proficiency in analyzing complex financial data using software like Loan Origination Systems (LOS) or similar platforms. call hr aditi@7795311459 call Nihala@7795311104 call Ruth@9590520040

Roles and Responsibilities Review loan applications to determine creditworthiness of borrowers. Analyze financial statements, tax returns, and other relevant documents to assess borrower's credit risk. Conduct thorough analysis of applicant's financial situation using various tools such as DTI ratios, FICO scores, etc. Verify income documentation through employment verification calls or third-party vendors. Make informed decisions on approving or denying loans based on risk assessment. Desired Candidate Profile 1-6 years of experience in mortgage underwriting with a focus on conventional loans (FHA & VA). Strong understanding of US residential mortgage industry regulations and guidelines. Proficiency in analyzing complex financial data using software like Loan Origination Systems (LOS) or similar platforms. call hr Aditi@7795311459 call hr ruth@9590520040

Roles and Responsibilities Review loan applications to determine creditworthiness of borrowers. Analyze financial statements, tax returns, and other relevant documents to assess borrower's credit risk. Conduct thorough analysis of applicant's financial situation using various tools such as DTI ratios, FICO scores, etc. Verify income documentation through employment verification calls or third-party vendors. Make informed decisions on approving or denying loans based on risk assessment. Desired Candidate Profile 1-6 years of experience in mortgage underwriting with a focus on conventional loans (FHA & VA). Strong understanding of US residential mortgage industry regulations and guidelines. Proficiency in analyzing complex financial data using software like Loan Origination Systems (LOS) or similar platforms. call@7816842400 call@7849020010 call@7848820045 call@7848820048

Role & responsibilities Experience: - 3-6 years Responsibilities: Lead process and automation design in ongoing project. Review consultants/ equipment suppliers documents for design, requirement and GxP compliance. Lead equipment/ system packages in facility and equipment FAT, installations, SAT, Facility start-up, Support process systems IQ/OQs, PQs, engineering batches. Prepare/ support preparation/ review of URS, DQ. Lead procurement related activities for equipment. Preferred candidate profile A degree in chemical engineering with 6-8 years of experience in design/ manufacturing/ any technical services for pharma/ biopharma facilities. Shall have knowledge of pharma GMP, ISPE, ASME BPE guidelines. Shall be proficient with operations and design of CIP and SIP. Experience in biotech plants/ experience in biotech manufacturing is highly preferred. Shall be able perform and review heat/ mass balance and utility calculations. Perks and benefits To the industry standards

Role & responsibilities Experience: - 3-6 years Responsibilities: Support process and automation design in ongoing project. Review consultants/ equipment suppliers documents for design, requirement and GxP compliance. Support / actively participate in facility and equipment FAT, installations, SAT, Facility start-up, IQ/OQs, PQs, engineering batches. Support preparation/ review of URS, DQ. Support procurement related activities for equipment. Preferred candidate profile A degree in chemical engineering with 3-5 years of experience in design/ manufacturing/ any technical services for pharma/ biopharma facilities. Shall have knowledge of pharma GMP guidelines. Knowledge in biotech plants/ experience in biotech manufacturing is an advantage. Shall be able to understand and perform basic heat/ mass balance and utility calculations. Perks and benefits To the industry standards

Role & responsibilities Job responsibilities comprise carrying out of Quality Assurance functions in day-to-day activities. JOB RESPONSIBILTY 1. Responsible for review, approvals and close outs of change controls, deviations, CAPA, incident reports and any other quality system documents 2. Develop, manage and improve Quality Systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards in support of CGxP activities 3. Review and approvals of analytical and formulation development Master documents. 4. Review and approval of analytical activities protocols and reports 5. Submitting whole set of documents required for regulatory submissions for new products 6. Supporting for any regulatory queries from QA perspective 7. Review and approval of validation, qualifications protocols and reports, 8. Monitoring day to day activities in Analytical development and Formulation development in compliance to the GMP 9. Preparation, review and approval of SOPs 10. Conducting training on SOPs, quality management systems and GMP in all aspects including procedural updates 11. Control of documents includes documents storage, issuance, distribution, retrieval and destruction 12. Performing vendor audits of API and Excipients (where necessary) and handling of all activities related to vendor audits 13. Conduct periodic audits of CMOs and Althera affiliate facilities. Participate in the vendor Qualification programme as and when needed. 14. Review and approve change control initiated at CMOs and co-ordination with European QA, RA aid customers and keep track till all the relevant activities are completed 15. Planning and conducting of self-inspection, preparing and sending self-inspection reports to concerned departments. Verifying the self-inspection compliance report for correctness and completion 16. Oversight and coordination with the Contract Manufacturing Organization (CMOs) on batches manufacturing activities as well Quality Management functions for Althera products 17. Coordination with the European QA team on supplying necessary QMS documents as required 18. Responsible for review, approvals and close outs of deviations, CAPA, OOS, OOT and incident reports raised by the CMOs. Timely review of effectiveness of CAP As. 19. Participate in investigations at the CMOs where necessary, review and ensure the investigations are conducted in line with the current regulatory expectations. 20. Applying risk management tools wherever applicable in accordance with current regulatory requirements 21. Handling of Market complaints and to co-ordinate with respective CMOs to get the investigation done on timely manner with appropriate root causes and CAPAs identified. 22. Track all the QMS status of Althera products at CMOs are timely concluded, and reports are shared 23. Coordinate with CMOs in any Regulatory and customer audits at their site, track all the observations and the CAPAs are completed timely as per the commitment. 24. Review and approve of CMOs validation and master documents (BMRs, BPRs, MFR, PVPs, PVRs etc) and Protocols (Validation, Qualification, cleaning, stability etc) 25. Oversee, support and coordinate with Althera affiliate manufacturing and Testing sites and the RnD site. 26. Preparation, Review of the PQRs for Althera products. 27. Ensure quality / technical agreements with contract manufacturing organizations (CMOs)are available and updated within timelines. Preferred candidate profile Perks and benefits best in the industry

Job Responsibilities To ensure QMS are in place at CML in line with GMP requirements / Quality standards / applicable regulatory requirements. To review and identify the critical control points for each product and to ensure respective process controls are implemented at CML. To ensure products are manufactured, tested, and released at CMLs as per approved batch records & specifications. To provide support to CML’s to achieve all time GMP compliance. To ensure all current version of forwarded documents are used for manufacturing and testing of products. To keep track of all CAPAs and review the CAPA implementation status so that Quality sustainability is achieved. Responsible for identification, assessment, and mitigation of risks at CMLs. To participate in any new product Trials /Technology transfers /Site transfers at new /existing sites. To investigate product failures, market complaints, non -conformances with root cause analysis & ensure robust CAPA’s is defined. To ensure completion of activities in line with Quality Road map. Maintaining master list of documents and ensuring implementation of current version of below documents: 1.Batch records (BMR / BPR) 2.Specifications, STP’s, GTP’s (RM / PM/ FG) 3.Artwork & Shade cards Identification & escalation of gaps in manufacturing / packing process between BMR / BPR Vs Actual. To review practices and data of Environmental, Water trends, cleaning validation, etc. on Monthly basis. To review the Analytical data, logbooks, instrumentation data to ensure CMLs are performing analysis as per approved test methods. To perform terminal inspection for the batches in-warded at respective CML/CFA/Mother warehouse. To share the discrepancies of terminal inspection to Compliance team at CML and to follow-up for investigation reports and CAPA of the same. To share the terminal inspection reports to HWC – HO. Trending of terminal inspection data – Location wise and share the trends to Compliance team at CML and HWC-HO. Escalate any Non-conformance/ Deviation from standard procedures/ GMP violations which lead to business risk / product Quality to HOD-QA. Any other Job responsibilities assigned by the Reporting Manager.

IPQA SPECIALIST

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top management level professionals according to clients specific needs. We are BEST-FIT Recruitment Riders do exactly what our name tells. To know more about us please visit our website: www.bestfitrecruitment.co.in We would like to inform you that presently we have professional career opportunity matching to your profile with one of our esteemed client. Please see the following position summary: Client: Subsidiary of the American MNC Pharma Company Position: Assistant Manager - QA (Green Field Project) Location: Dahej, Gujarat Job Profile: Projects Cycle management for Validation & Qualification of Green Field Projects. Document Preparation of all phases of Validation of major from scratch. Conducting QA validation lifecycle documentations. Preparing & reviewing of documentations related to URS, DQ, IQ, OQ & PQ Preparation & Reviews of documents related to Validation Master Plan & Project Validation Plant, Validation Protocol & Reports, and Qualification related documents. Assist in the monitoring and periodic revalidation of equipment and processes. Follow all regulatory guidelines & cGMP guidelines, as required by the job function. Liaise with key personnel within project teams to ensure validation tasks are completed in a timely manner Work to create an environment of open communication, participation and information-sharing within and between teams within QA and throughout facility. Desired Profile: Graduate Engineer in any Discipline with 5 to 7 years experience in QA documentations especially in Green Field Projects. Preferably worked in Pharma with experience in Documentation related to URS, DQ, IQ, OQ & PQ. Exposure to Green field Projects would be first preference. Expertise in preparing documentations related to green field projects with Parma. Extremely meticulous, methodical & process oriented Stay informed about advancements in QA, regulatory requirements, & industry trends. Continuously expanding knowledge & skills to enhance performance and contribute to continuous improvement initiatives. Recruiter Profile: BEST - FIT Recruitment Riders G-7, Amrit Complex, Opp: Mahavir Jain Vidhyalaya & Jain Derasar, R.V. Desai Road, Near Goyagate Circle, Vadodara-390001, Gujarat, India E-Mail: hrd@bfrr.in Website: www.bestfitrecruitment.co.in

About Us: Unison Pharmaceuticals Private Limited (Formerly known as Unison Pharmaceuticals) was established in 1981 with a vision of providing quality & most affordable medicines across the nation. The company is having 1st Rank (Unit wise sales) in Gujarat state since more than 17 consecutive years as per ORG IMS. In addition to this, the company is ranked 82 among top companies of India (Rupee wise sales) MAT December 2021. Website : www.unisonpharmaceuticals.com We are seeking specialists for multiple roles into Quality Assurance at our EU Approved OSD Manufacturing facility at Unit I Moraiya, Ahmedabad. Company : Unison Pharmaceuticals pvt ltd. Location : Unit I (Moraiya, Ahmedabad) - Transportation provided from Ahmedabad routes (1) Quality Assurance - Validation Designation: Sr. Executive /Assistant Manager /Dy. Manager Education Qualification: B.Pharm/M.Sc/M.Pharm Experience Required: 8 to 12 years Job Exposure required: Must Have : Process Validation, Cleaning Validation Preferred to have: QMS, Risk Management, Qualification (2) Quality Assurance - Compliance & Training Management Designation: Executive / Sr. Executive Education Qualification: B.Pharm/M.Sc/M.Pharm Experience Required: 6 to 10 years Job Exposure required: Must Have : Audit Compliance, Training Management (3) Quality Assurance - Documentation Designation: Officer / Sr. Officer / Executive Education Qualification: B.Pharm/M.Sc/M.Pharm/B.Sc Experience Required: 4 to 7 Years Job Exposure required: Must Have : APQR or IPQA & Batch Record Preparation (4) Quality Assurance - Process Validation Designation: Officer / Sr. Officer / Executive Education Qualification: B.Pharm/M.Sc/M.Pharm/B.Sc Experience Required: 5 to 8 Years Job Exposure required: Must Have : Process Validation, Hold Time Study (5) Quality Assurance - IPQA - Packing Designation: Officer / Sr. Officer / Executive Education Qualification: B.Pharm/M.Sc/M.Pharm/B.Sc Experience Required: 4 to 8 Years Job Exposure required: Must Have : In process QA , Line clearance of Packing area Perks & Benefits Dynamic work environment Career development opportunities Work-life balance Free transportation Free insurance coverage for self, spouse, and kids Range of learning opportunities to help employees grow and thrive If you are passionate about continuing to work in the pharmaceutical industry and possess the required skills, we encourage you to apply for this position. Please submit your resume to career@unisonpharmaceuticals.com to be considered for this role. Join our team at Unison Pharmaceuticals and take the first step towards a rewarding career.

Lovely Professional University is looking for people in administrative profiles under the various divisions. Job Role : Administrative Handle the day to day administrative tasks such as preparing reports and managing general office activities. Required Qualifications & Skills: Minimum Master's degree in any discipline Experience : 0 to 5 years Excellent communication and interpersonal skills to work effectively Strong organisation skills to manage multiple tasks and prioritise work effectively Proficient with relevant software such as MS Excel, Microsoft Office etc. Job Location :- Phagwara Punjab To apply: https://forms.gle/cDvgN41aMYgzvUWB6