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3.0 - 7.0 years
0 Lacs
ankleshwar, gujarat
On-site
Role Overview: As a Senior QC Officer reporting to the Head QC, you will be responsible for performing various Quality Control activities in the pharmaceutical industry. Your role will involve ensuring that all QC activities are conducted according to defined Standard Operating Procedures (SOP) and documented promptly. You will have a crucial role in analyzing raw materials, in-process materials, equipment cleaning verification, vendor qualification, and finished product samples accurately and on time. Additionally, you will be required to calibrate QC instruments daily, prepare and maintain standard solutions, and generate certificates of analysis post-analysis. Your contribution will also ...
Posted 4 weeks ago
4.0 - 8.0 years
2 - 6 Lacs
aurangabad
Work from Office
Roles and Responsibilities Conduct market complaint investigations, deviation management, and OOS/OOT handling according to established procedures. Ensure compliance with regulatory requirements through vendor qualification, equipment qualification, cleaning validation, water validation, injectable processing, and process validation. Collaborate with cross-functional teams to resolve quality issues and implement corrective actions. Develop and maintain documentation related to quality control processes. Provide technical support for product testing and analysis. Desired Candidate Profile 4-8 years of experience in Quality Assurance (QA) or a related field within the pharmaceutical industry. ...
Posted 4 weeks ago
10.0 - 15.0 years
8 - 12 Lacs
aurangabad
Work from Office
Roles and Responsibilities Ensure compliance with GLP guidelines, including investigation of OOS/OOT events and vendor qualification. Maintain accurate records of GLP documents, instruments, and equipment through preventive maintenance schedules. Conduct calibrations on instruments according to CGMP requirements and perform spares management tasks. Implement LIMS system for effective inventory control and HPLC analysis. Perform CAPA activities as needed to resolve quality issues. Desired Candidate Profile MS/M.Sc(Science) degree in Chemistry or Organic Chemistry from a recognized university. Minimum 10-15 years of experience in pharmaceutical industry with expertise in GLP practices. Strong ...
Posted 4 weeks ago
3.0 - 7.0 years
2 - 4 Lacs
nalagarh, baddi
Work from Office
We have urgent Requirement for : Department : Quality Assurance Designation : Executive Skills Required : Process Validation, Equipment Qualification, QMS, APQR, Capa, Cleaning Validation. Experience Required : 03 to 08 years Salary : Depend upon Interview Location : Nalagarh interested candidate can contact @ 7717304694 or can send their Resume at hr2@theonpharma.com
Posted 1 month ago
0.0 - 1.0 years
2 - 3 Lacs
gurugram
Work from Office
Role & responsibilities 1.Vendor Qualification 2.Compliance Management 3.Support in Ghiloth Project 4.Harmonization of SOPs. Preferred candidate profile M. Pharma Passout freshers Benefits and Perks: 5.5 Days Working(2nd,4th Saturday and 5th Saturday off) Fixed Day shift Pf,Bonus and Gratuity Near Guru Dronacharya Metro Station
Posted 1 month ago
3.0 - 7.0 years
0 Lacs
palghar, maharashtra
On-site
As a Vendor Quality Assurance Specialist, your role is crucial in ensuring that all vendors supplying materials meet the company's quality standards and regulatory requirements through a structured vendor qualification and evaluation process. Key Responsibilities: - Initiate and coordinate vendor qualification activities for both new and existing vendors. - Prepare and maintain vendor qualification dossiers and files to ensure documentation accuracy. - Coordinate with procurement and other departments to gather necessary vendor data and documentation efficiently. - Ensure vendors comply with Good Manufacturing Practices (GMP), regulatory requirements, and company quality standards to uphold ...
Posted 1 month ago
4.0 - 8.0 years
4 - 6 Lacs
bharuch, dahej
Work from Office
Handle quality complaints, aberrations & compliance, Perform RA, RCA, CAPA, Review &approve deviation, batch record, change control, CAPA, SOP, QMS documents, test method, sampling, Vendor Mgt, dispatch, Approve & review validation/qualficn protocols Required Candidate profile M.Sc.(Chem/Pharma) with 4 to 8 yrs exp in API industry. Knowledge of quality systems, legal documentation & Compliance, instrument handling & calibration, Instruments , Root Cause Analysis Techniques
Posted 1 month ago
0.0 years
0 Lacs
mumbai, maharashtra, india
On-site
End to end responsible to ensure optimal quality standards, cost effectiveness and customer satisfaction through efficient use of raw materials and mix designs at all plants in the cluster. Implement best quality practices in order to enhance overall product quality of AAA RMC. Responsibilities 1.Meeting with architects and consultants to understand customer requirements and manage escalated customer complaints in quality and continually monitor the products. 2.Continually look at mix optimization and reduction in mix costs through trials on new or different raw materials and by any other method. 3.Interact with customers and understand their specific requirements to allow mix designs to be ...
Posted 1 month ago
8.0 - 13.0 years
8 - 12 Lacs
palghar
Work from Office
Manage QMS docs per regulatory standards. Prepare, review QRA, validation, complaints, audits, PQR, SMF, manuals. Align with teams, support audits, SOPs, training, reviews, and drive continuous improvement. Perks and benefits Bachelor's Accommodation and Travelling benefit.
Posted 1 month ago
2.0 - 6.0 years
4 - 4 Lacs
mumbai
Work from Office
Responsibilities: Conduct process validation studies Ensure compliance with regulatory requirements Manage vendor qualifications Lead cleaning validation processes Oversee IPQA activities Flexi working
Posted 1 month ago
5.0 - 10.0 years
5 - 8 Lacs
jadcherla
Work from Office
Key Responsibilities: 1. Execution of Plant-Level Validation Activities Coordinate and execute process validation, cleaning validation, and hold time studies on shop floor. Monitor and record critical process parameters (CPPs) during validation batches. Ensure adherence to batch manufacturing records (BMRs) and protocols during execution. 2. Documentation & Review Prepare and review process validation protocols, reports, and summary documents . Maintain validation documentation as per SOPs and data integrity requirements. Compile analytical results and production data for validation reports. 3. Compliance & GMP Adherence Ensure execution is in compliance with SOPs, cGMP, and regulatory guide...
Posted 1 month ago
15.0 - 20.0 years
0 Lacs
karnataka
On-site
As a qualified candidate, you will be leading the Quality Assurance, QC Chemistry, and Microbiology Laboratories for the site. Your role will involve developing Standard Operating Procedures (SOPs), ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory guidelines, and monitoring day-to-day department activities. Responsibilities include reviewing and approving documents, executing in-process controls, participating in investigations, vendor qualification, stability management, and ensuring safety practices. - You will be responsible for organizing the recruitment and training of QA (Quality Assurance) and laboratory personnel for chemistry and microbiology labor...
Posted 1 month ago
8.0 - 12.0 years
0 Lacs
haryana
On-site
As a Procurement Engineer, your role involves conducting procurement activities with both local and foreign vendors in adherence to the company's procedures, code of ethics, local content regulations, and QHSE policy. This includes managing procurement processes for mechanical equipment and package items such as Raw gas Compressors, Dehydration units, Gas Sweetening systems, Chiller units, Air Coolers, Pumps, Heat Exchangers, Vessels, Tanks, OH cranes, Chemical Injection Skids, and more. Your key responsibilities will include: - Requesting commercial offers and aligning material requests with supplier proposals - Coordinating with the technical department to resolve discrepancies - Evaluatin...
Posted 1 month ago
0.0 - 2.0 years
2 - 3 Lacs
ahmedabad
Work from Office
• Assigning batch details • Preparing the batch CoAs • Keeping the entry of Inward and Outward details • Regulatory market review or our products and verify guidelines Required Candidate profile Candidates with excellent knowledge in COA, Batch Details, Batch Record, Vendor qualification, CAPA, Customer Query resolution.
Posted 1 month ago
5.0 - 8.0 years
4 - 9 Lacs
pune
Work from Office
Roles and Responsibilities Execute equipment qualification, validation, cleaning validation, vendor qualification activities according to SOPs and regulatory requirements. Conduct process validation protocols, reports preparation, and review of documents. Ensure compliance with cGMP guidelines during execution of QA activities. Collaborate with cross-functional teams to resolve issues related to QA operations. Maintain accurate records of all QA activities and documentation.
Posted 1 month ago
3.0 - 8.0 years
8 - 16 Lacs
visakhapatnam
Work from Office
Job Purpose We are looking for a qualified IT QA professional to support the implementation, validation, and compliance of electronic systems in accordance with global regulatory standards. The role ensures the effective functioning of key systems like TrackWise, AmpleLogic, LIMS, SAP, and eLMS while driving data integrity, compliance, and quality excellence across business operations. Roles & Key Responsibilities Ensure implementation and compliance of electronic systems (TrackWise, AmpleLogic, LIMS, SAP, eLMS, MES) as per global regulatory guidelines (USFDA, EU, WHO, PMDA, CDSCO, etc.). Review and support validation/qualification of software (DQ, IQ, OQ, PQ), ensuring timely closure of pro...
Posted 1 month ago
5.0 - 8.0 years
5 - 15 Lacs
visakhapatnam
Work from Office
Job Purpose We are looking for a qualified IT QA professional to support the implementation, validation, and compliance of electronic systems in accordance with global regulatory standards. The role ensures the effective functioning of key systems like TrackWise, AmpleLogic, LIMS, SAP, and eLMS while driving data integrity, compliance, and quality excellence across business operations. Roles & Key Responsibilities Ensure implementation and compliance of electronic systems (TrackWise, AmpleLogic, LIMS, SAP, eLMS, MES) as per global regulatory guidelines (USFDA, EU, WHO, PMDA, CDSCO, etc.). Review and support validation/qualification of software (DQ, IQ, OQ, PQ), ensuring timely closure of pro...
Posted 1 month ago
0.0 - 3.0 years
2 - 5 Lacs
hyderabad
Work from Office
We seek a passionate Product Development Food Technologist to spearhead the creation of innovative and nutritious food products for babies, pregnant mothers, and new mothers at Rorosaur Foodtech Private Limited. As a key member of our New Product Development department, you will be instrumental in shaping the future of early childhood nutrition in India. This role encompasses the entire product lifecycle, from initial concept and formulation to nutritional and stability testing, label development, and ensuring compliance with FSSAI guidelines. The ideal candidate will possess a strong foundation in food science, a creative mindset, and a commitment to delivering high-quality, safe, and nutri...
Posted 1 month ago
8.0 - 13.0 years
9 - 12 Lacs
baddi
Work from Office
Following will be the responsibilities of the position holder: 1. To ensure cGMP compliance at site. 2. Responsible for Vendor Qualification and Management 3. Day-to-day coordination with QA-representative w.r.t. Vendor Qualification/Re-Qualification and Management status. 4. To review vendor documents for Vendor Qualification. 5. To perform the Vendor audit and its compliance for RM/PM. 6. To prepare Vendor Audit Report and confirm the compliance. 7. To Review and Approve the Approved Vendor List of RM/PM. 8. To Review/Approve Annual vendor audit Planner/Scheduler. 9. To receive the pre-purchase samples through Purchase Team and send it to QC/ARD for further assessment. 10. To review the Pr...
Posted 1 month ago
2.0 - 3.0 years
2 - 3 Lacs
vapi
Work from Office
Responsible for IPQA, line clearance, preventive maintenance checks, BMR/BPR review, vendor qualification, audit support, QAMS documentation, APQR preparation, and compliance verification across departments. Required Candidate profile M.Sc or M.Pharm or BSc or BPharm 2-3 Years 2.5 to 3.5 LPA
Posted 1 month ago
0.0 - 3.0 years
2 - 4 Lacs
mangaluru
Work from Office
Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review
Posted 1 month ago
0.0 - 3.0 years
2 - 4 Lacs
mangaluru
Work from Office
Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review
Posted 1 month ago
15.0 - 19.0 years
0 Lacs
hyderabad, telangana
On-site
As a key member of the team at a leading manufacturer of active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry, your primary responsibilities will include leading R&D CRO projects for global customers. You will be tasked with developing non-infringing routes for APIs with sustainable processes, focusing on Impurity synthesis. Additionally, you will play a crucial role in developing robust, scaleable, operationally safe, and commercially viable processes. This includes synthesis route selection, lab feasibility, process optimization, technology transfer, and scale-up & commercialization for tonnage scale campaigns, always prioritizing saf...
Posted 1 month ago
2.0 - 6.0 years
0 - 0 Lacs
ankleshwar, gujarat
On-site
As a Senior QA Officer, your role will involve various responsibilities to ensure quality assurance within the API pharma industry. You will be tasked with issuing Batch Manufacturing Records, equipment cleaning records, logbooks, and analytical reports for raw materials, finished products, and packing materials. Additionally, you will assist in the preparation of SOPs for different departments and conduct plant rounds to verify documents according to cGMP and GLP norms. Line clearance activities for manufacturing and packaging, issuing deviation forms, change control forms, and handling customer complaints will also be part of your duties. You will review and verify analytical and Batch Man...
Posted 1 month ago
7.0 - 12.0 years
5 - 8 Lacs
bengaluru
Work from Office
Role & responsibilities Activities to be performed with the compliance of ISMS requirements by means of confidentiality, integrity, and availability. Data integrity must be followed and ensured in all the respective responsibilities. Audits: Sponsor Audits: Managing the sponsor audits as a whole, from pre requestees to close out meeting. Addressing audit observations within timeline. Follow up sponsors for certificates/clearance. Standard Audits: Ensuring the readiness for Audit. Supporting the cross functions for readiness requirements. Managing the audit from open meeting to close out meeting. Addressing the observations. Vendor Audits: Initiating the vendor qualification process based on ...
Posted 2 months ago
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