39 Deviations Jobs - Page 2

Role & responsibilities Analytical QA Review the analytical documents which are generated after analysis of Drug Products. Preparation and Review of all Departmental SOP's for cGMP Compliance. Compilation and Review of the Batch Records, Certificate of Analysis, Analytical Protocol, etc which are required for release of Batches. Review and Approve SOPs, Change Controls, Deviations, Annual Product Quality Reviews, Incident Reports, Out of Calibrations, Out of Specifications, Out of Trends, Approve the Investigation Reports. Market Compliant, & manage Stability Samples etc. Review of Regulatory Requirements and its Compliance. Periodic review of all Quality functions and Procedure for appropri...

You will be responsible for preparing and reviewing the master documents of sterile manufacturing for the parenteral facility. Additionally, you will prepare and review protocols and reports based on the specified requirements. Document management and preparation tasks such as BMRs, BPRs, and master SOPs will also fall under your responsibilities. Handling change control, deviations, CAPA, investigations, and providing training to subordinates, technicians, and operators within the department are key aspects of this role. You will also be accountable for audit and compliance on the manufacturing shop floor. The ideal candidate for this position should hold a B.Pharm/M.Pharm degree and posses...

We are seeking skilled and dedicated individuals to join our Quality Assurance (QA) department at Fido Pharma Private Limited, an esteemed pharmaceutical company located at Plot No: 108-109, Global Industrial Park, Mauli, Barwala, Panchkula, Haryana. If you have a background in B.Pharm / M.Pharm / M.Sc. and a passion for ensuring quality in pharmaceutical products, we have the following positions available: QA Manager: As a QA Manager, you will lead our Quality Assurance department, overseeing adherence to GMP and regulatory guidelines such as EU-GMP and WHO-GMP. Your responsibilities will include managing document control, validations, change control, Vendor Qualification, CAPA, deviations,...

As a Quality Assurance Specialist, your primary responsibility will be to handle Change Management, Deviations, Out of Trend, Out of Specification, and CAPA closure before the product release. This includes coordinating QMS activities in the Track Wise system and managing documents through the SAP system. It is essential to track and complete all QMS activities within the specified due date. You will be tasked with coordinating complaint investigations, managing Return Goods, and handling Recalls. Additionally, reviewing contract manufacturing and testing documents such as executed BPR and Analytical reports will be part of your duties. Your role will involve performing unplanned audits on t...

Date: 2 Jul 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Essential Functions Job Description Job Title: QMS Project Reviewer Job Location: Syngene International Limited, Bengaluru About Syngene : Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation f...

The Quality Assurance (QA) Executive API (Bulk Drugs) role based in Savli, Gujarat requires a candidate with 2-5 years of experience and a qualification of B.Sc / M.Sc. As a QA Executive, your responsibilities will involve ensuring compliance with cGMP, ICH, and regulatory guidelines in API (bulk drug) manufacturing. You will be responsible for preparing, reviewing, and controlling SOPs, BMRs, BPRs, change controls, deviations, and CAPAs. In addition, conducting in-process checks for manufacturing and packaging activities, handling investigations for deviations, OOS/OOT results, and supporting root cause analysis are key components of this role. You will also be involved in participating in ...

As a QA Assistant Manager with 5-7 years of experience in the pharmaceutical industry, you will be responsible for running the department independently. Your role will require strong skills in inter and intra-departmental communication, a desire to learn, and the ability to adapt and adopt to people and systems effectively. This position is based in Mumbai. Your key responsibilities will include: - Skilled handling of FDA-GMP audits to ensure compliance with regulatory standards. - Experience in establishing robust Quality Management Systems (QMS) to ensure compliance with GLP and cGMP standards. - Expertise in creating, reviewing, and maintaining Standard Operating Procedures (SOPs). - Mana...

As a QA/QC Engineer at SPECTRON Engineers Private Limited in Mumbai, you will be responsible for developing and implementing QA/QC procedures for both on-site and off-site project execution. Your key responsibilities will include conducting inspections and quality control of electrical, instrumentation, and mechanical works, reviewing WPS, PQR, ITPs, method statements, and third-party test reports, performing material inspection, calibration of instruments, and equipment verification. You will also be coordinating with clients, third-party inspectors, and internal teams for quality audits, ensuring compliance with applicable standards such as IS, API, ISO, and ASTM, as well as project specif...

You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. You will also handle Return Goods and ensure the smooth functioning of the quality system by performing risk assessments as required. Conducting regular internal audits and reviewing/approving all documents including SOPs, Spec & STPs, Forms, protocols, and reports will be part of your duties. Additionally, you will review annual product quality review reports, provide training on cGMP topics to employees, and support customer audits/visits as well as regulatory audits. You will assist in providing necessary docume...

You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. In addition, you will handle Return Goods and ensure the proper functioning of the quality system by performing risk assessments as needed. Conducting regular internal audits will also be part of your duties. Reviewing and approving all documents including SOPs, Spec & STPs, Forms, protocols, and reports will be crucial to ensure compliance. You will also review annual product quality review reports and provide training on cGMP topics to employees at the site. Additionally, you will support customer audits/visits a...

You will be responsible for performing line clearance activities before commencing operations, ensuring a clean and sanitized visual inspection and Packing area, and following the preventive maintenance schedule of machines. Operating the machines efficiently and filling the log of general areas as per SOP and work execution will also be part of your responsibilities. It is essential to adhere to cGMP, GDP, and maintain discipline in the department while ensuring that all employees comply with the same standards. Your role will involve ensuring that all equipment and production lines are in validated and calibrated status, preparing daily production reports based on achieved targets, and cre...

Role & responsibilities To maintain the QA documents in compliance state and ensure they are all time ready for internal and external audits. Preparation and review of SOPs. To act as training coordinator and oversee implementation & compliance of training matrix. To maintain the vendor approval document. Daily issuance and retrieval of records of other departments. To maintain records of change control, deviations, CAPA, incidents logs, OOS, OOT. To prepare and maintain calibration and validation schedules of equipments as per VMP. Upkeep and follow-up for new product licenses. To prepare APR, trends. Prepare and review of BMR and analytical reports. Upkeep of retain samples and controls sa...

Job Description : Business: Pharma Solutions Department: Engineering Location: Digwal Travel: NA Job Overview To maintain the GMP & EHS Documentation related to E&M Key Stakeholders: Internal Production, QA, EHS Key Stakeholders: External Regulatory, Customer Reporting Structure AGM - E&M Positions that report into this role Executive/ Sr. Executive / Dy. Manager Experience 12 years and above Job Description: Responsible for carrying preventive maintenance as per schedule. Should be capable of handling Quality, EHS Audits. Should have in-depth knowledge in cGMP/USFDA Documentation Should have in-depth knowledge in Current safety systems/safe working practices. Person should be capable to Tra...

Role & responsibilities The Deputy Manager - CSV will be responsible for overseeing the validation of computerized systems in manufacturing and laboratory environments, ensuring compliance with regulatory standards and best practices. This role requires strong technical knowledge, attention to detail, and effective communication skills to collaborate with various stakeholders. Desired Candidate Profile : The candidate must have a minimum of 5 years of experience in the pharmaceutical industry, with at least 5 years focused on end-to-end Computerized Systems Validation (CSV) for manufacturing and laboratory equipment. Detail-oriented, with primary responsibilities including authoring in-house...