123 Market Complaints Jobs

You will be responsible for the following tasks as part of the role: - Execution of WL Protocol at each site - Reviewing the outcomes of protocol-based studies as outlined in the FDA commitment - Conducting protocol-based retrospective reviews of investigations (deviations, OOS and OOAL) of product batches within shelf life - Conducting protocol-based retrospective reviews of investigations related to market complaints - Developing a protocol for Material system assessment and suitability of vendors and implementing enhanced processes at all sites - Reviewing high-risk Investigation reports before batch disposition - Categorizing defects in the Visual Inspection program as critical, major, a...

WL Protocol Execution at each site Review of outcome of protocol-based studies as outlined in the FDA commitment Protocol based retrospective review of investigations (deviations, OOS and OOAL) of product batches within shelf life Protocol based Retrospective review of investigations related to market complaints Protocol for Material system assessment and suitability of vendors Implement enhanced process at all sites Review of high-risk Investigation reports before batch disposition Visual Inspection program - Defect categorization for critical, major, and minor defects Implement SOP on QRM for Injectable product Defect across all Amneal sites Protocol for assessment for QU authority and res...

(QMS) implementation, Manage Change Control, Deviations, and CAPA to maintain product quality. Conduct Vendor Qualification & audits. Ensure GMP practice. Stability Studies & ensure compliance with ICH guidelines. Time Studies & process optimization.

As a Packaging Development team member at Dr. Reddys Laboratories Ltd., your role will involve new launch and lifecycle management of Injectable products, as well as execution of projects driven by packaging development. **Roles & Responsibilities:** - Maintain Design History File for combination products for its lifecycle management. - Prepare Design History File for site transfer of combination products. - Get involved in design verification phase of combination product development and contribute. - Handle market complaints and create investigation report to find out root cause and appropriate CAPA. - Create awareness of combination product requirement across cross functional team. - Creat...

Job Description JOB Responsibilities: - Location: Ahmedabad 1. Ensuring the GMP compliance at CMO and Release of batch manufactured for US market at CMU. 2. Monitoring of process starting from dispensing to packing including witness analysis of Lupin products manufactured at CMO for US market and Domestic market. 3. Handling of market complaint with root cause identification and ensuring the CAPA implementation. 4. New product review to be carried out at manufacturing site after availability of all the documents. 5. Review and authorize Master Batch Records, stability protocol, process validation protocol, temperature cycling protocol, specification of in-process, intermediate and finished p...

Role Overview: You will play a crucial role in leading downstream manufacturing compliance and ensuring quality management systems in line with cGMP and regulatory requirements at a sterile pharmaceutical manufacturing unit. Your contribution will directly impact patients by maintaining the excellence of every product delivered by the company. Your responsibilities will include handling change control management, coordinating with investigators for CAPA identification, reviewing and approving manufacturing records, ensuring compliance to audit observations, monitoring training metrics, and supporting site inspection readiness programs. Key Responsibilities: - Lead downstream manufacturing co...

Job Title: Manager - Regulatory Affairs / Quality Assurance Company: GreenSignal Bio Pharma Pvt Ltd Location: Gummidipoondi, Chennai, Tamil Nadu Experience: 10-15 years in Quality Assurance and Regulatory Affairs, specifically within the Vaccine, Injectable, and Sterile Industry Educational Qualification: Bachelors or Masters in Pharmacy M.Sc in Biotechnology, Microbiology, or a related field Additional qualifications in life sciences or pharmaceutical sciences are a plus Job Overview: As the Manager QA / Regulatory Affairs , you will play a pivotal role in ensuring that our vaccine , injectable , and sterile pharmaceutical products meet global regulatory requirements and quality assurance (...

1. Quality System Management: Establish, implement, and maintain the Quality Management System (QMS) as per cGMP, WHO, and regulatory norms . Oversee activities related to change control, deviations, CAPA, OOS/OOT investigations, and risk assessments . Ensure all QA processes align with company policies and current regulatory requirements. 2. Documentation & Compliance: Review and approve SOPs, BMRs, BPRs, validation protocols , and analytical reports. Ensure all documentation complies with Good Documentation Practices (GDP) and data integrity requirements. Supervise document control , issuance, archival, and version management systems. 3. Batch Release & In-Process Quality Assurance: Ensure...

Be responsible to lead downstream manufacturing compliance. Ensure quality management systems in line with cGMP and regulatory requirements and handling training requirements Handling Change control management system including CCF impact assessment, preapproval, cross functional CCF evaluation, monitoring of closure of change controls and change control action item. Coordinate with investigator in identifying appropriate CAPA and tracking for closure of the CAPA. Responsible for the review and approval of Master manufacturing records for the commercial batches. Responsible for review and approval of scale up, exhibit, intended and Process validation master manufacturing records. To review an...

Role & responsibilities: Preparation and review of SOP. Preparation and monitoring of change control, deviation control. Review and approve the Standard Operation Procedure, Product Quality Reporting System (PQRS), Change control, Deviation controls/Analytical Protocols/Stability protocols/Qualification and validation protocols and reports. In-Process checking during online activities. To ensure timely submission of audit compliances for the deficiency during the inspections/audits Monitoring of GMP compliance. Review of quality documents and analytical data as per pharmacopeia specification, STP, batch card, stability finish product, packaging materials for the purpose of compilation of dos...

To handle Market complaints, perform investigation and protocol based study to determine root cause. To determine the investigation plan and carry out investigations using appropriate root cause analysis tools, assessing the risk associated with them and to derive the appropriate CAPA. To handle the recommended CAPA and to verify the implementation of recommended actions as per CAPA system and to evaluate effectiveness checks of implemented CAPA. To handle the proposed changes as per the change control procedure. To assess the risk / impact associated with proposed change and to verify the implementation of action plan as per approved change control form Responsible for the review of SOPs of...

Role & responsibilities : We are looking for multiple positions from IPQA to QMS aspects, experienced between 2 years to 12 years in OSD formulation QA with B.Pharma/M.Pharma background. Preferred candidate profile : candidates having exposures on IPQA, line clearance, BMR BPR Review, CAPA management, Market compliant investigation, Change control, validations and qualification, vendor management and audit compliances.

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

Job Description: Require experience in IPQA, IPQA (API), Qualification (API), Validation (API), Analytical QA, APQR, Stability Studies, regulatory affairs, OOS investigation, Risk Assessment, Market Complaint, QA Documentation, Exposure in QMS, Deviation, CAPA etc with Trackwise system. Qualification - B.Sc./M.Sc./ B.Pharma/ M.Pharma. Experience - 04 to 09 Years. Role & responsibilities Preferred candidate profile The candidate from API background Only to apply. Send CV with Sub : Forwarding CV for position of QA dept to jagpal.dewal@ipca.com

To follow the safety rules in the premises according to the company norms To handle Quality Management Documents like Change Control, Deviation etc To prepare Failure Investigation Reports against Quality impacting deviations, Out-of- Specifications and Non-Conformances To ensure investigations are evaluated and closed out in a timely manner to meet business needs Responsible for cGMP compliance related to CAPA implementation and to ensure the timely closure of CAPA To review, develop and introduce systems, practices and cultural changes that enable the department to meet business demands within agreed time frames and expected GXP standards To perform risk analysis for different process or p...

Initiate and conduct investigations associated with sterile injectable product manufacturing and processing. To identify true root causes through different tool and identify SMART CAPAs. Review of investigations to ensure content of report in compliance to the site procedure requirements for its completeness, accuracy and adequacy. To investigation market complaints, identify the root causes and respond to partner/customer. To monitor overall investigations matrixes and present to management time to time. Responsible for Quality compliance within the investigation process. Actively involved in regulatory audits as a process SME. Provide management timely updates on critical events. To sustai...

Senior Manager 1

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. Candidate should be resident or ready to relocate either Palghar or Boisar / Virar (Mumbai) Should know regulated market CMO Knowledge of dosage forms like OSD, Semisolids, Liquids, parentals Quality- Should know to deliver products with all quality standards. SAP-Material Planning (RM/PM); Inventory control. Supply Planning-finished goods replenishment, production planning....

Key Responsibilities : 1. Documentation & Compliance Ensure compliance with cGMP, WHO, EU GMP, USFDA, and other regulatory requirements specific to injectable formulations. Review, control, and maintain SOPs, Quality Manuals, and other QMS documents. Control issuance, retrieval, and archival of GMP documents as per SOPs. 2. Deviations & CAPA Investigation and documentation of deviations, incidents, and non-conformances. Identify root causes using tools like 5 Whys / Fishbone analysis. Initiate, track, and ensure timely closure of Corrective and Preventive Actions (CAPA). 3. Change Control Review and manage Change Control records related to injectable manufacturing. Ensure impact assessments ...

Role Overview: As an Assistant Manager Quality Assurance at a Global Pharmaceutical MNC based in Mumbai, your role will be crucial in ensuring high-quality standards across product development, manufacturing, and distribution in alignment with company values and regulatory compliance. Key Responsibilities: - Manage and maintain quality systems across manufacturing, development, analytical, and warehousing sites. - Conduct regular audits of CMOs/CDMOs, analytical labs, warehouses, and RM/PM vendors. - Support regulatory audits, handle global quality queries, and ensure compliance with cGMP/GLP and evolving drug regulations. - Prepare and maintain quality-related SOPs and agreements with exter...

Responsible for ensuring the effective implementation of Quality Assurance (QA) systems in strict compliance with GMP , regulatory requirements, and internal quality standards. Actively supports continuous improvement initiatives across key areas including production processes , documentation practices , internal and external audits , and supplier quality management , promoting a culture of quality and compliance throughout the organization.

Role & responsibilities APLHC Unit IV (Naidupeta, Tirupati Dist., Andhra Pradesh) Open Functions: Quality Control/Quality Assurance Experience Required: 1 - 6 years in USFDA Approved pharmaceutical manufacturing facility Quality Control and Quality Assurance Job Titles & Grades: Executive / Sr. Executive (based on experience) Job Description: QC Routine & stability testing of RM / IP / FP samples on HPLC, GC, LCMS, UV, etc. Prepare/standardize analytical methods, calibration & instrument qualification (IQ/OQ/PQ) Adhere to GDP, ALCOA+ and cGMP guidelines; ensure timely LIMS/SAP data entry Investigate OOS/OOT results and implement effective CAPA Support regulatory, customer and internal audits...

Roles and Responsibilities 1. Responsible for implementation & monitoring of cGMP/GDP practices at site. 2. Responsible for periodic review of all quality Documents for appropriateness. 3. Preparation of SOPs and handling of QMS tools like deviation change control, CAPA. 4. Responsible for approval/rejection of deviations /change controls pertaining to corporate activities. 5. Oversee the team of technical personnel handling order processing artworks finalization BOM updating of products and follow ups. 6. Responsible for co-ordination and submission of Quality documents for regulatory submissions. 7. Responsible for maintenance, periodical update and review of technical agreements with dome...

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. ...

A highly skilled professional responsible for management of market complaints/investigations at site, including receipt, logging, and further tracking. Timely follow-ups and effective communication within quality team and other relevant stakeholders. Ability to perform the investigations thoroughly. Strong capabilities in data interpretations and root cause identification. Ability to prepare risk assessments. Detailed investigation reports preparation/writeups skills. Initiating and managing CAPAs through Trackwise system, ensuring timely implementation and closure. Effective collaboration with cross-functional teams to support Field Alert Reports (FARs), product recall associated activities...