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3.0 - 4.0 years
1 - 3 Lacs
coimbatore
Work from Office
Job Summary The Policy Servicing Specialist will be responsible for managing and maintaining life and annuities insurance policies. This role requires a keen eye for detail and proficiency in MS Office to ensure accurate policy servicing. The candidate will work in a hybrid model primarily during day shifts with no travel required. The role is crucial in supporting the companys mission to provide exceptional insurance services. Responsibilities Manage and maintain life and annuities insurance policies to ensure accuracy and compliance with company standards. Utilize MS Office tools to efficiently process and update policy information. Collaborate with internal teams to resolve policy-related inquiries and issues promptly. Ensure all policy servicing activities adhere to regulatory requirements and company guidelines. Provide exceptional customer service by addressing policyholder queries and concerns effectively. Analyze policy data to identify trends and recommend improvements in servicing processes. Prepare detailed reports on policy servicing activities for management review. Coordinate with underwriters to facilitate policy amendments and endorsements. Conduct regular audits of policy records to maintain data integrity. Support the development and implementation of new policy servicing procedures. Participate in training sessions to stay updated on industry trends and best practices. Contribute to team meetings by sharing insights and suggestions for process enhancements. Assist in the onboarding of new team members by providing guidance and support. Qualifications Demonstrate proficiency in MS Office particularly Excel and Word to manage policy data efficiently. Possess strong knowledge of life and annuities insurance to handle policy servicing tasks effectively. Exhibit excellent communication skills to interact with policyholders and internal teams. Show attention to detail to ensure accuracy in policy documentation and servicing. Have the ability to work independently in a hybrid work model managing time effectively. Display problem-solving skills to address policy-related issues promptly. Maintain a customer-centric approach to deliver high-quality service. Certifications Required Certified Insurance Service Representative (CISR) or equivalent certification in life and annuities insurance.
Posted 1 week ago
10.0 - 12.0 years
5 - 10 Lacs
ghaziabad
Work from Office
Role & responsibilities 1. Managing the quality documents and conducting internal Audit & data review etc. 2. Maintaining all records and documentation as per 17025:20053. 3. Maintaining regularly and tracked calibration and standard log books, 4. Directing all quality activities for the laboratory such as ILC, IQC, Training, etc. 5. Preparing compliance report for the audit or for the closure of various shortcomings or NCs. 6. Having sound knowledge of QMS and LIMS. 7. Knowledge of 21cfr, OOS, Market complaints, APQR.
Posted 1 week ago
8.0 - 13.0 years
0 - 1 Lacs
hosur
Work from Office
Job Title: Manager Quality Assurance (QA) Company: Global Calcium Pvt. Ltd. Location: Unit III – Hosur, Tamil Nadu Experience: 10+ years Qualification: B.Pharm / M.Pharm / M.Sc or equivalent Job Description: We are looking for an experienced Manager – QA to lead our Quality Assurance team at Global Calcium Pvt. Ltd., Unit III (Hosur). Key Responsibilities: Lead Quality Management System (QMS) activities in compliance with cGMP and regulatory requirements. Manage validation and qualification of equipment, utilities, and processes. Ensure audit readiness and compliance with regulatory agencies (USFDA, EU, WHO, MHRA). Review and approve SOPs, protocols, and reports related to validation and qualification. Handle internal audits, external inspections, and CAPA implementation. Guide, mentor, and develop the QA team to strengthen the quality culture. Desired Candidate Profile: 10+ years of experience in QA in the pharmaceutical industry. Strong knowledge of QMS, Validation & Qualification. Excellent communication and leadership skills. Exposure to international regulatory guidelines preferred. Salary: Best in the industry (not a constraint for the right candidate). Industry Type: Pharmaceuticals / API / Bulk Drugs Functional Area: Quality Assurance Employment Type: Full Time, Permanent How to Apply: Interested candidates may share their CV to suganya@globalcalciumpharma.in with the subject line “Application for Manager – QA” .
Posted 1 week ago
3.0 - 5.0 years
3 - 5 Lacs
jammu
Work from Office
Key Responsibilities: Expert in handling Track wise system. Having exposure of handling of QMS tasks, OOS,OOT, Deviation, Change control, CAPA ,Market complaint and maintain the quality management system. SOP preparations and review.
Posted 1 week ago
8.0 - 10.0 years
7 - 10 Lacs
baddi
Work from Office
Key Responsibilities: Conduct comprehensive Risk Assessments to ensure robust quality controls Lead Investigation Reviews & Approvals with cross-functional teams Manage Change Control & CAPA processes for continuous improvement Execute SAP BOM Updates with precision and accuracy Oversee LIMS & DMS Activities for data integrity and documentation compliance Drive QMS Trending & Reporting to support strategic decision-making Prepare and review SOPs in alignment with regulatory standards Benefits other than CTC: Insurance - (Health, Life & Accidental) Transportation (Air Conditioned) from nearby locations like Chandigarh, Panchkula etc Alternate Saturday Off
Posted 2 weeks ago
3.0 - 5.0 years
0 - 0 Lacs
hyderabad
Work from Office
Dear All, Greetings from Aizant Drug Research Solutions!! We are looking for a motivated professional with strong expertise in Cleaning Validation (QA Formulations) to join our Quality Assurance team. The ideal candidate should have hands-on experience in planning, executing, and documenting cleaning validation activities as per regulatory requirements. Experience: 3-5 Years Location: Hyderabad(Dulapally) Department: Quality Assurance(Formulations) Key Responsibilities: -Preparation and review of Cleaning Validation protocols, reports, and risk assessments. -Execution and monitoring of Cleaning Validation studies as per cGMP guidelines. -Identification of worst-case products and development of cleaning validation strategies. -Preparation and review of SOPs related to cleaning and validation activities. -Review of analytical method suitability for cleaning validation. -Handling deviations, CAPA, and change controls related to cleaning validation. -Coordination with cross-functional teams (Production, QC, Regulatory, etc.) for smooth execution. -Ensuring compliance with international regulatory requirements (USFDA, EMA, MHRA, WHO, etc.). -Sound knowledge of cGMP, regulatory guidelines, and risk-based approach to cleaning validation. -Strong documentation and review skills. If interested, please share your updated resume at raghuveera.vutla@aizant.com Note: Immediate Joiners are more preferred
Posted 2 weeks ago
2.0 - 5.0 years
3 - 8 Lacs
ankleshwar
Work from Office
Production GMP coordinator To initiate change control, preparation of draft documents (Existing and proposed) of change control. To discuss the changes with QA and to take approval. To initiate investigation and preparation of OOS, OOT and deviation investigation report of respective plant and ensure timely closer of documents. Preparation of new SOP and revised existing SOP as per requirement and initiation in documentum software and to take approval. To perform daily GMP round in respective plant and ensure compliance and online documentation. Monitor the Change control, CAPA and deviation in track wise system and its tracking and closures of respective plants and ensure timely closer of documents. To give training on approved documents, awareness session and ensure compliance of training of all employee of respective plant documents. Preparation of validation protocol and reports and verify that the validation protocols and reports are reviewed and approved. Analyse observations in order to compliance to cGMP systems & regulatory requirements. Involve in qualification of new or modified facilities and equipments. Handling of Trackwise, Documentum (D2), ZYTIMS, SAP and LIMS function.
Posted 2 weeks ago
7.0 - 12.0 years
5 - 8 Lacs
visakhapatnam
Work from Office
We are looking for a meticulous Asst. Manager Production to lead production activities at Synnat Pharma Private Limited, ensuring seamless API manufacturing operations and adherence to the highest quality standards. As Asst. Manager Production, you will play a pivotal role in overseeing daily production activities, monitoring validation batches, and ensuring compliance with cGMP guidelines. Your responsibilities will include the preparation and review of production-related documents, coordination with cross-functional teams, and active participation in internal and external audits. You will also be responsible for identifying and resolving operational gaps, managing deviations and Out-of-Specification (OOS) incidents, and implementing Corrective and Preventive Actions (CAPA). With a strong focus on process optimization and continuous improvement, you will contribute to enhancing production efficiency and maintaining a facility that is always audit-ready. Your expertise in QMS (Quality Management Systems) and experience with ERP systems (SAP) will be crucial in driving operational excellence and ensuring the delivery of high-quality pharmaceutical products. Responsibilities: Oversee daily API production activities, ensuring compliance with established procedures and cGMP guidelines. Monitor validation batches, process parameters, and Batch Manufacturing Records (BMR/MBMR) for accuracy. Verify online BMRs and ensure compliance with regulatory and documentation standards. Coordinate with utility, QC, Stores, and Engineering teams to support seamless production operations. Supervise movement of finished products, intermediates, and recover solvents as per protocols. Identify and resolve operational gaps at the floor level to improve efficiency. Manage deviations, Out-of-Specification (OOS) incidents, and implement CAPA measures effectively. Ensure compliance with QMS and audit requirements; participate in internal and external audits. Prepare, review, and maintain accurate production documents, including validation protocols and training records. Develop preventive maintenance schedules, monthly production plans, and calculate raw material requirements. Train and mentor team members on production processes, compliance, and quality standards. Report production activities, deviations, and audit compliance to management while driving process improvements. General Expectations and Past Experiences: Strong understanding of API Manufacturing processes and cGMP guidelines. Demonstrated experience in preparing and reviewing production-related documents, including BMRs, validation protocols, and SOPs. Proven ability to manage and resolve deviations and Out-of-Specification (OOS) incidents effectively. Proficiency in using ERP Systems (SAP) for production planning, inventory management, and data analysis. Experience in participating in and contributing to successful internal and external audits. Strong leadership and communication skills with the ability to train and mentor production staff. In-depth knowledge of Cleaning Validation procedures and QMS (Quality Management Systems).
Posted 2 weeks ago
4.0 - 8.0 years
6 - 10 Lacs
ahmedabad
Work from Office
Role & responsibilities Contributing to maintain or improve quality performance and compliance of operational PV activities Ensuring Deviation and CAPA Management, Change Control, Document Control, and other Quality Management System activities Developing, managing, and executing quality management processes to ensure quality standards are maintained and compliant with regulatory requirements Coordinating PV audits and Inspections Preparation and management of Pharmacovigilance System Master File (PSMF) Generation, quality review, and distribution of compliance and quality metrics and trending activities. Coordinating compliance, quality, and process improvement initiatives while providing input into corrective/preventative actions and effectiveness measures for Corrective and Preventative Action plans (CAPA), as appropriate Preparation, review, and maintenance of safety data exchange agreement/pharmacovigilance agreement/any other agreement. Management of the Quality document (SOPs/Policy/Conventions) planning and their compliance. Training management and documentation Ensuring the third parties (Business partners and vendors) qualifications and its documentation Collaborating with key stakeholders to ensure metrics meet oversight needs Coordinate with vendor for activities like Computer system Validation, User Management, Database Training, WHODD, MedDRA Version update, etc Continuous Monitoring of Regulatory Requirements (Surveillance) Management of Company Product Dictionary Handling archival and retrieval activities of pharmacovigilance-related documents Preferred candidate profile Candidate must have minimum 3 years experience in PV-Compliance. Candidate must have relevant knowledge of all PV areas like ICSR, aggregate reports, medical writing etc.. Candidate must be ready to work in office.
Posted 2 weeks ago
2.0 - 3.0 years
2 - 3 Lacs
dharuhera, rewari
Work from Office
•Ensure timely completion of Product/Raw Materials analysis and timely release of RM/PM/ Finished Goods in SAP. •Ensuring achievement of production targets as per the HACCP, FSSC 22000 - product quality, hygiene, GMP, PRP and food safety etc.
Posted 2 weeks ago
7.0 - 12.0 years
7 - 10 Lacs
kheda, ahmedabad
Work from Office
Designation - Sr. Executive / Asst. Manager - Quality Assurance Company - Leading Pharma Raw Material Mfg. Company Job Location - Ahmedabad Qualification - B.Sc. / M.Sc. / B.E.- Chemical / B.Pharm Experience - Min. 6+yrs. and above Required Candidate profile Company coming up with Greenfield Project Responsible for handling QA / GMP Related documentation QMS, Audit Preparation, Vendor Questionnaire, Market Compliant & Customer Compliance
Posted 2 weeks ago
3.0 - 4.0 years
3 - 3 Lacs
amritsar
Work from Office
Role & responsibilities Complete knowledge of Validation ( AHU / Autoclave / Dry Heat Sterilizer etc ) and Calibration -Capable of Compiling the Validation and calibration Activities -Good Computer Skill Preferred candidate profile CLEAN SHAVEN MALE CANDIDATE WITH MINIMUM 2-3 YEARS EXPERIENCE IN STERILE INJECTION SECTION
Posted 2 weeks ago
5.0 - 9.0 years
0 Lacs
telangana
On-site
More than 5 years of experience in Quality Management Systems (QMS), including handling of change control, deviations, OOS, and Audit readiness. Proficient in electronic systems such as Trackwise and SAP. Qualifications: - MSc in Chemistry or BTech in Chemical Engineering Piramal Group, with three decades of existence, has strategically grown through both organic and inorganic means. Committed to inclusive growth and ethical practices, the group values equal employment opportunities. Employment decisions are merit-based, considering qualifications, skills, performance, and achievements. The group ensures equal opportunities for all applicants and employees in recruitment, training, promotion, compensation, and benefits, among others. About the Team: Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) providing end-to-end solutions across the drug life cycle. The globally integrated network of facilities in North America, Europe, and Asia enables services like drug discovery, process development, clinical trial supplies, commercial APIs, and finished dosage forms. Specialized services include highly potent APIs, sterile fill/finish, peptide products, and biologics. PPS is a trusted partner for innovators and generic companies, offering expertise across diverse technologies.,
Posted 2 weeks ago
2.0 - 5.0 years
4 - 8 Lacs
baddi
Work from Office
Job Description To ensure implementation of current good warehousing practicein warehouse, To ensure all the activities in warehouse are perform as perSOP, Follow-up with QC for material release, Handling of psychotropic rejected and expired materialrecords Physical stock reconciliation Preparation of job responsibilities Follow up with purchase department regarding short fall ofRaw Material Preparation and Revision of SOP as per requirement, Monitoring of packing material dispensing Manpower handling Generation of Daily Dispensing Report, Generation of monthly report like stock statement, due forretest, under retest,ageing, Maintaining the audit supporting document & dailydocuments for the Department Knowledge of handling of process related document like CCP/ deviation& implementation, Coordinate with purchase department and vendor for deliveryof Material
Posted 2 weeks ago
5.0 - 10.0 years
7 - 12 Lacs
mumbai
Work from Office
As an Assistant Manager in the Contracts_WMEL team, you will be responsible for managing and overseeing all aspects of contract administration within the organization. This includes but is not limited to drafting, reviewing, and negotiating contracts, ensuring compliance with labor laws and statutory requirements, and managing relationships with stakeholders. You will also be responsible for preparing and maintaining all necessary documentation and reports related to contracts.
Posted 2 weeks ago
10.0 - 15.0 years
8 - 18 Lacs
ahmedabad
Work from Office
Unison Pharmaceuticals is seeking candidates for the role of Engineering QMS - Lead for our EU Approved Facility, Unit III Company : Unison Pharmaceuticals Ltd. Location : Moraiya, Ahmedabad - Unit III Designation : Upto Manager Job Role/Position: Engineering QMS - Lead Experience Required : 1015 Years (Pharma Industry OSD preferred) Key Responsibilities Preparation, review, and implementation of SOPs in line with GMP compliance . Review and control of daily operation logbooks and engineering documentation . Operation & Maintenance knowledge of utility equipment, HVAC, and water systems . Handling breakdown maintenance of utility and process equipment. Initiation, handling, and documentation of QMS activities : Change Control, Deviation, CAPA, etc. (EQMS software exposure preferred). Departmental training coordination and managing training records in TIMS software . Preparation & review of Preventive Maintenance (PM) planners/records . Preparation & review of Calibration planners, records, and certificates . Coordination and follow-up for calibration/validation activities . Qualification/Validation of HVAC and Utility systems, including preparation & review of DQ, IQ, OQ, PQ, RQ documents . Exposure to PLC/SCADA validation of utility & process equipment (CSV). Review & evaluation of breakdown maintenance sheets for utilities/process equipment. Review & updating of plant and utility drawings . Participation in regulatory and customer audits . Desired Candidate Profile B.E./B.Tech in relevant engineering field. 1015 years of Engineering-QMS experience in a pharmaceutical OSD facility . Strong knowledge of GMP guidelines, regulatory requirements, and audit readiness . Hands-on exposure to QMS software, training tools, and compliance systems . Excellent leadership, coordination, and documentation skills. What We Offer Opportunity to work with a growing and reputed pharma company. Exposure to global regulatory audits and modern EQMS systems . Professional growth with continuous learning and development. Interested candidates can share their CVs at sandipnair@unisonpharmaceuticals.com with subject line: Application for Engineering – QMS” Regards Sandip HR Department
Posted 2 weeks ago
15.0 - 19.0 years
0 Lacs
navi mumbai, maharashtra
On-site
As the Head of Global Quality at our company based in Navi Mumbai, India, you will play a crucial role in leading the development and execution of quality assurance strategies that align with our long-term goals. Partnering closely with the Chief Technical Officer (CTO) and the Leadership Team, you will ensure the implementation of robust quality management systems, regulatory compliance, and a continuous improvement in operational performance. Your responsibilities will include establishing best-in-class quality goals, performing quality metrics trending, and implementing problem-solving and system improvements to meet target levels of quality. You will lead and manage the quality teams across all manufacturing facilities with a focus on continuous improvement. Additionally, you will be responsible for team building, training, mentoring, and managing a team of QA professionals in the adoption of new processes and tools. Collaboration with business units to develop quality targets for new and existing products, managing quality projects resulting from site consolidations and acquisitions, and working on simplification and harmonization of quality systems are also part of your role. You will oversee the effectiveness of the Quality System across all manufacturing sites, implement vendor/supplier development processes, and maintain compliance with the Global Quality Management System. Furthermore, you will drive recruitment activities, assure the ongoing professional development of direct reports and the quality organization, establish standards/metrics for exponential growth while adhering to quality standards and regulatory guidelines, and participate in functional meetings. Your responsibilities will also include leading QA teams in global sites, promoting customer-centric approaches, using CAPA systems for process improvement, preparing sites for regulatory agency inspections, and participating in due diligence, transition, and integration in acquisition projects. The essential qualifications, experience, and skills required for this role include an M.Pharm/B.Pharm/Master's in Science, 15+ years of leadership experience in Quality Assurance preferably in the pharmaceutical or life sciences industry, strong understanding of regulatory landscapes in semi-regulated markets and international quality standards, exceptional commercial acumen, and strategic business insight. Excellent consulting and communication skills, personal credibility, interpersonal skills, integrity, dependability, and the ability to work cross-culturally and cross-functionally are also essential for this role.,
Posted 2 weeks ago
1.0 - 4.0 years
3 - 5 Lacs
bengaluru
Work from Office
Job Summary Join our dynamic team as a Customer Service Specialist where you will play a crucial role in enhancing customer satisfaction through effective communication and problem-solving. With a focus on travel management and reservation systems you will utilize your expertise in MS Excel to streamline processes and ensure seamless service delivery. This work-from-home position offers a day shift schedule providing flexibility and work-life balance. Responsibilities Provide exceptional customer service by addressing inquiries and resolving issues promptly to ensure customer satisfaction. Utilize travel management skills to assist customers with booking and managing their travel plans efficiently. Leverage MS Excel to analyze data and generate reports that support decision-making and improve service delivery. Collaborate with team members to develop and implement strategies that enhance the customer experience. Maintain accurate records of customer interactions and transactions to ensure data integrity and compliance. Communicate effectively with customers to understand their needs and provide tailored solutions. Monitor customer feedback and identify areas for improvement to enhance service quality. Assist in the development of training materials and resources to support team members in delivering exceptional service. Stay updated on industry trends and best practices to continuously improve service offerings. Coordinate with internal departments to ensure seamless service delivery and resolve any operational issues. Support the reservation process by providing expert guidance and assistance to customers. Ensure compliance with company policies and procedures to maintain high standards of service. Contribute to the companys purpose by delivering services that positively impact society and enhance customer satisfaction. Qualifications Demonstrate proficiency in customer service with a strong focus on travel management. Exhibit advanced skills in MS Excel for data analysis and reporting. Possess excellent communication and problem-solving abilities. Show experience in reservation systems as a valuable asset. Display a proactive approach to identifying and addressing customer needs. Maintain a high level of attention to detail and accuracy in all tasks. Adapt to a work-from-home environment with strong self-motivation and discipline. Certifications Required Certified Customer Service Professional (CCSP) or equivalent certification in customer service.
Posted 2 weeks ago
5.0 - 10.0 years
6 - 9 Lacs
ahmedabad
Work from Office
Role & responsibilities To Handle batch release and stability testing of various biological products like GCSF, EPO, Vaccines Calibration and Performance Verification of Instruments Management of Reference Standard Review of the analytical data Management of Deviation, OOS & OOT, CAPA and Change control Validation of excel sheet Department training coordinator Management of Analyst Qualification Preparation of GMP documents such as Standard Test Procedure, Standard Operation Procedure, Performance verification protocol, Method Validation report, Data Recording Sheet, Specifications Quality softwares i.e. TIMS, LIMS
Posted 2 weeks ago
4.0 - 7.0 years
5 - 7 Lacs
nagpur
Work from Office
Job Description Required for IPQA acitities. Required for Batch manufacturing record review. Required for line clearnace and other shop floor related activity of QA. Work Experience 3 to 8 years. Education Graduation in Pharmacy Competencies
Posted 2 weeks ago
3.0 - 7.0 years
0 Lacs
ahmedabad, gujarat
On-site
Responsible for any packaging related activities in development lab or GMP area. Preparation of Master Packaging Card (MPC), batch packaging record (BPR) along with other GMP & Non GMP packaging documents (protocols, reports etc). Development of New change parts for blister packing. Review of executed and master batch packaging records. Taking care of GMP documentation including change control, SOP, deviation, market complain etc. Innovator pack analysis and report preparation. Preparations of departmental SOP. Initiation of Change control, Deviation and CAPA in Track Wise for Packaging related activities. Coordination with supplier for development of new/existing Packaging Materials or change parts. Coordination with Analytical, Formulation & Warehouse departments for analytical activities of Packaging Materials. Packing of Clinical/Developmental batches at pilot & formulation development lab. Periodic review of packaging materials inventory and initiating PR for the packaging material order/procurement. Preparation / Review of Master Packaging card, Bill of Materials and Batch Packaging Record. Monitoring inventory for packaging material and purchase of new materials. Preparation / Review of Specification/ STP/SOP of Packaging materials. Effective communication with Client for Packaging related matter. Reference Product pack analysis and preparation of pack characterization report. Initiation of change control, Deviation and CAPA in Track Wise for Packaging related activities. Coordination with supplier for development of new/ existing Packaging materials or change parts or new packaging instrument/ equipment. Coordination with Formulation development for Packaging related activities. Trouble shooting for Packaging related activities. Calibration & qualification of packaging related instrument/ equipment. Follow gxp (GMP, GDP, GLP, etc.) For all the processes. M. pharm/B. Pharm, candidate with IIP will be added advantage. In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limiteds investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.,
Posted 2 weeks ago
2.0 - 5.0 years
2 - 3 Lacs
dadra & nagar haveli, silvassa
Work from Office
Role & responsibilities 1. Documentation Issuance & Control - Issue Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and logbooks to production as per SOP. - Maintain master documents for BMR, BPR, SOPs, and other controlled documents with proper version control. - Implement and maintain document control systems as per GDP and cGMP requirements. 2. Batch Record Review & Compliance - Review executed BMR and BPR for completeness, accuracy, and compliance with approved specifications. - Coordinate with production to resolve discrepancies, deviations, and documentation errors. 3. SOP & Change Control - Assist in preparation, review, and revision of SOPs related to QA and documentation practices. - Support change control, deviation, and CAPA processes related to documentation. 4. Audit & Regulatory Support - Ensure readiness for internal and external audits by maintaining accurate documentation. - Provide necessary documents and records during inspections (USFDA, WHO, MHRA, etc.). 5. Training & Coordination - Train production and QA staff on Good Documentation Practices (GDP) and documentation SOPs. - Coordinate with other departments for timely closure of documentation requirements. 6. Data Integrity & Archiving - Ensure compliance with data integrity principles in all document handling activities. - Maintain systematic archival of controlled documents for easy retrieval and regulatory compliance.
Posted 2 weeks ago
0.0 - 5.0 years
1 - 5 Lacs
kheda, nadiad, dholka
Work from Office
Job Title: Quality Assurance Officers (4 Positions) Company: Nourish Pharmaceutical Pvt Ltd Location: Kheda, Gujarat Job Type: Full-time Nourish Pharmaceutical Pvt Ltd is a leading pharmaceutical company committed to delivering high-quality products. We're expanding our Quality Assurance team and looking for talented professionals to join us. Positions: 1. Quality Assurance Officer - Production 2. Quality Assurance Officer - QMS 3. Quality Assurance Officer - Validation & Qualification 4. Quality Assurance Document Control Officer Job Descriptions: 1. Quality Assurance Officer - Production - Key Responsibilities: - Ensure cGMP compliance in production areas - Manage and review Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and Master Formula Records (MFRs) in Pharma Cloud - Conduct in-process quality checks and documentation - Verify dispensing activities and line clearance - Collaborate with production team to ensure quality and compliance - Core Skills: - Attention to detail and analytical skills - Strong knowledge of cGMP, SOPs, and quality control procedures - Excellent communication and interpersonal skills - Experience & Qualification: - 0-3 years of experience in a similar role within the pharmaceutical industry - B.Pharm or M.Pharm degree in Pharmacy or a related field - Certification in quality assurance or a related field is an added advantage 2. Quality Assurance Officer - QMS - Key Responsibilities: - Manage deviations, CAPAs, and document handling - Ensure compliance with Quality Management System (QMS) standards - Conduct internal audits and facilitate external audits - Review and update SOPs, policies, and procedures - Collaborate with departments to ensure quality and compliance - Core Skills: - Strong analytical and problem-solving skills - Excellent communication and interpersonal skills - Ability to work independently and prioritize tasks - Experience & Qualification: - 1-3 years of experience in a similar role within the pharmaceutical industry - B.Pharm or M.Pharm degree in Pharmacy or a related field - Certification in quality assurance or a related field is an added advantage 3. Quality Assurance Officer - Validation & Qualification - Key Responsibilities: - Plan, coordinate, and execute validation and qualification activities - Ensure compliance with validation and qualification protocols - Review and approve validation reports and documentation - Collaborate with departments to ensure quality and compliance - Identify and mitigate risks associated with validation and qualification - Core Skills: - Strong knowledge of validation and qualification procedures - Excellent analytical and problem-solving skills - Ability to work independently and prioritize tasks - Experience & Qualification: - 1-5 years of experience in a similar role within the pharmaceutical industry - B.Pharm or M.Pharm degree in Pharmacy or a related field - Certification in validation and qualification or a related field is an added advantage 4. Quality Assurance Document Control Officer - Key Responsibilities: - Manage and maintain document control system - Implement and maintain change control system - Issue and maintain logbooks and records - Ensure plant and product documentation is accurate and compliant - Collaborate with QA team to ensure document accuracy and compliance - Core Skills: - Attention to detail and organizational skills - Basic knowledge of cGMP and quality control procedures - Excellent communication and interpersonal skills - Experience & Qualification: - 0-2 years of experience in a similar role within the pharmaceutical industry - B.Pharm, B.Sc or M.Pharm degree in Pharmacy or a related field - Certification in validation and qualification or a related field is an added advantage - All positions open for Fresher B.Pharm or M.Pharm degree in Pharmacy, Willingness to learn and grow in a quality assurance role How to Apply: If you're a motivated and detail-oriented individual with a passion for quality assurance, please submit your resume to info@nourishpharma.com
Posted 3 weeks ago
12.0 - 17.0 years
12 - 20 Lacs
mumbai, india
Work from Office
USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors. We have a presence in over 65 countries with our dynamic team of over 7,000 across generations. Our commitment to brand building is evident in our popular products like Glycomet GP, Ecosprin AV, Jalra, Tazloc, Glynase, MVI and more. Join USV and be part of our journey as we continue to innovate, transform lives, and shape the future of healthcare. Job Title: Manager / Sr. Manager (Quality Assurance) - API Only Designation - Manager / Sr. Manager - CQA - API Direct Reportees: No Location: HO @ Govandi, Mumbai Working Days: 5 days from Office + Alternate Saturdays - 1st, 3rd & 5th Working (sometimes 2-3 days in a month to sites depends on work) Job Responsibilities: Must have audit handling experience for regulatory agencies audits like USFDA, EMA, ANIVSA, CDSCO etc Must have technical knowledge and well versed with regulatory & cGMP requirements Monitoring and Assessment of Quality Management System (QMS) for manufacturing sites and R&D functions. Hands on experience in industry software like TWD, SAP HANA, LIMS, DMS etc., Review of Customer Complaints, Risk Assessments, Deviations, CAPAs, Investigations, Recalls etc. - QMS Handling of Customer Quality agreement and co-ordination with cross functional team till execution of the agreement. Tracking of CQA SOPs as per the review date, by maintaining the SOP Periodic review tracker and master SOP list. Preparation/Revision of CQA SOPs and making master, effective after completion of training. Review of Master formula and technology transfer documents for API sites. To provide training of SOPs, cGMP, or other modules as per the requirement. Review of SOPs related to various departments. Scheduling and participation in self-audits (Sites and corporate functions). Regulatory and customer audit support to sites. Review of Specifications for raw material, intermediate, finished API, working standard, GTPs of API Sites. Handling Customer Questionnaires, Regulatory Agencies Questionnaires and Customer queries as per the requirement. Participation in Quality related meetings. Education: Min. Qualification Required - B.Pharm./M.Pharm/M.Sc. Experience: Minimum 13-17 years
Posted 3 weeks ago
2.0 - 4.0 years
11 - 15 Lacs
pune
Work from Office
Overview The Enterprise Operations and Quality team oversees the data, services, and applications within the Climate and Sustainability Engineering and MSCI's Data Technology verticals. Our primary responsibility is to manage and support end-to-end Quality Engineering by creating tools and tests that ensure continuous quality assessment of applications, services, and generated data. MSCI is renowned for its high-quality data, which is crucial for critical investment decisions, and our role is vital to this mission. Responsibilities Develop and implement engineering solutions to address complex data validation challenges. Develop code in Python and/or Java to maintain high-quality data integrity. Design and implement automation frameworks (distinct from traditional Selenium-based programs) to test data dimensions across complex environments, with the capability to handle big data. Qualifications Hands on experience of day to day development of data critical applications 3-7 years of experience in quality engineering. Proficiency in coding with Python and Java. This is a technical role, not a managerial position. What we offer you Transparent compensation schemes and comprehensive employee benefits, tailored to your location, ensuring your financial security, health, and overall wellbeing. Flexible working arrangements, advanced technology, and collaborative workspaces. A culture of high performance and innovation where we experiment with new ideas and take responsibility for achieving results. A global network of talented colleagues, who inspire, support, and share their expertise to innovate and deliver for our clients. Global Orientation program to kickstart your journey, followed by access to our Learning@MSCI platform, LinkedIn Learning Pro and tailored learning opportunities for ongoing skills development. Multi-directional career paths that offer professional growth and development through new challenges, internal mobility and expanded roles. We actively nurture an environment that builds a sense of inclusion belonging and connection, including eight Employee Resource Groups. All Abilities, Asian Support Network, Black Leadership Network, Climate Action Network, Hola! MSCI, Pride & Allies, Women in Tech, and Women’s Leadership Forum. At MSCI we are passionate about what we do, and we are inspired by our purpose – to power better investment decisions. You’ll be part of an industry-leading network of creative, curious, and entrepreneurial pioneers. This is a space where you can challenge yourself, set new standards and perform beyond expectations for yourself, our clients, and our industry. MSCI is a leading provider of critical decision support tools and services for the global investment community. With over 50 years of expertise in research, data, and technology, we power better investment decisions by enabling clients to understand and analyze key drivers of risk and return and confidently build more effective portfolios. We create industry-leading research-enhanced solutions that clients use to gain insight into and improve transparency across the investment process. MSCI Inc. is an equal opportunity employer. It is the policy of the firm to ensure equal employment opportunity without discrimination or harassment on the basis of race, color, religion, creed, age, sex, gender, gender identity, sexual orientation, national origin, citizenship, disability, marital and civil partnership/union status, pregnancy (including unlawful discrimination on the basis of a legally protected parental leave), veteran status, or any other characteristic protected by law. MSCI is also committed to working with and providing reasonable accommodations to individuals with disabilities. If you are an individual with a disability and would like to request a reasonable accommodation for any part of the application process, please email Disability.Assistance@msci.com and indicate the specifics of the assistance needed. Please note, this e-mail is intended only for individuals who are requesting a reasonable workplace accommodation; it is not intended for other inquiries. To all recruitment agencies MSCI does not accept unsolicited CVs/Resumes. Please do not forward CVs/Resumes to any MSCI employee, location, or website. MSCI is not responsible for any fees related to unsolicited CVs/Resumes. Note on recruitment scams We are aware of recruitment scams where fraudsters impersonating MSCI personnel may try and elicit personal information from job seekers. Read our full note on careers.msci.com
Posted 3 weeks ago
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