11 Deviations Jobs

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, and internal and external audits. You will be the main point of contact with regulatory bodies during inspections, ensuring timely compliance. Additionally, you will be responsible for developing and maintaining the company's quality systems and risk management strategy. Strong knowledge of cGMP, ICH, and regulatory requirements is essential for this role. Excellent communication, team management, and problem-solving skills are required. Previous experience in regulated manufacturing environments is preferred. Assistant Manager - Quality Assurance: In the role of Assistant Manager, you will provide support in managing and executing the site's quality systems, including change control, deviation handling, market complaints, and CAPA monitoring. You will assist in conducting periodic quality reviews and risk assessments and review batch documentation for accuracy and completeness. Internal audits, compliance activities, training sessions, and vendor qualification processes will also be among your responsibilities. A background in B.Pharm / M.Pharm / M.Sc. and 5-10 years of relevant experience are required for this role. Executive - Quality Assurance: As an Executive in the Quality Assurance department, you will be involved in line clearance and in-process quality assurance activities. Your duties will include maintaining documentation, supporting regulatory compliance, conducting internal audits, and assisting in vendor qualification processes. You will also participate in investigations of deviations, training programs, and vendor audits. Reviewing executed BMRs/BPRs, process control charts, and release documents will be part of your daily tasks. A background in B.Pharm / M.Pharm / M.Sc. and at least 1-6 years of experience are necessary for this role. If you are detail-oriented, proactive, and passionate about ensuring quality standards in the pharmaceutical industry, we invite you to apply for one of these exciting positions at Fido Pharma Private Limited. Join our team and contribute to the continual improvement of our quality systems and processes.,

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 the shop floor, monitoring the Manufacturing Process to identify root causes for product failures and cleaning incidents, and reviewing and closing Change control and related action items. Archiving of change control and other related documents will also fall under your purview. Preparation of Quality Assurance SOPs, reviewing plant SOPs, handling change control and deviations related to warehouse & SCM, and preparing and reviewing Risk Assessment reports for New Products & process change products are critical tasks that you will be responsible for. You will also be required to prepare risk assessments and declarations as per customer requirements and current guidelines. Reviewing Vendor Qualification documents, communicating with Vendors/Supply Chain Management, preparing Vendor audit schedules, implementing schedules as defined, maintaining SOP formats and Annexures, updating Approved Vendor lists periodically, and preparing and reviewing Annual Product Quality Reports and Product Quality metrics are key components of your role. Furthermore, you will review process validation protocols and reports, prepare and review cleaning validation protocols and reports, and handle any work assigned by your reporting Manager. In the absence of the position holder, operational responsibilities will be delegated to Direct reports or a designee.,

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 for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to companys integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Core Purpose Of The Role This is an exciting opportunity to play a role in drug substance development and manufacturing of Syngene. The role will provide exposure to handling clients across the globe, interaction with cross-functional departments and activities involved from product introduction to discontinuation. It provides an opportunity to learn different aspects of product development to commercial manufacturing. Role Accountabilities Follow GMP, GDP, and GLP procedures as applicable, while performing the assigned task. Create/ revise/ review of procedures (like SOP, protocols, calibration schedule, and other related documents as applicable.). Review and approval of Master BMR and PDR and its compliance. Review of TTD related to Late phase and commercial. Responsible for issuance and control of BMRs, PDRs, SOPs, EOPs and ECCs.Verify the product details, batch no., quantity, label, purchase order, RM issue slip, CoA, weights, packing and dispatch record, packing area (not limited to) and provide clearance to dispatch activity. Assessment of SOP vs guidelines for any gaps and taking appropriate actions. Investigate, review of investigation with respect to OOS/OOT and involve in the identification of root cause and to propose the CAPA for identified root cause. Preparation and review of QMS Trends (Deviation, LIR, OOS, OOT, Change control & Complaints). Handling of returned products and product recall. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience Demonstrated Capability Education Experience 3 - 6 years into Project related QMS activities (Change control, Deviations, CAPA, OOS, LIRs) Must have handled clients Expertise in review of Master Batch Record, Batch Record and Analytical Documents Knowledge on Good Documentation and laboratory practices Good coordination among CFTs Skills And Capabilities Expertise in handling QMS Activities Good knowledge about project related activities Client handling experience Master Batch Record, Batch Record and Analytical Document Review skills Specification and Method of analysis review Good communication skills Education MSc. Chemistry Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. Show more Show less

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 internal audits, regulatory audits (USFDA, EU, WHO, etc.), and vendor audits. Maintaining documentation for batch release, validation protocols, and quality systems, ensuring adherence to data integrity and good documentation practices (GDP), and supporting qualification and validation activities are crucial aspects of this position. Collaboration with cross-functional teams such as Production, QC, and R&D is essential for ensuring smooth operations. This is a full-time, permanent position with benefits including health insurance and Provident Fund. The work schedule is day shift with additional perks such as performance bonus and yearly bonus. The work location is in person.,

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). - Managing and implementing change control processes effectively. - Proficient in preparing and maintaining Site Master Files, Master Validation Plans, and Batch Manufacturing Records (BMRs). - Conducting stability studies, managing stability programs, and handling Out of Trend (OOT) and Out of Specification (OOS) results. - Establishing and maintaining standards according to current regulatory guidelines and Pharmacopeia revisions. - Evaluating deviations, managing change controls, and implementing corrective and preventive actions (CAPA). - Proficient in equipment qualification, process validation, cleaning validation, and method validation. - Overseeing the calibration of equipment and adhering to ICHQ7A guidelines and other regulatory standards. - Conducting trend analysis, providing feedback for continuous improvement, and implementing Quality Risk Management strategies. - Working towards continuous improvement of quality systems and efficiently managing Quality Control departments. - Handling ISO documentation procedures, including quality manuals, work instructions, checklists, and audits. - Managing sampling and testing of excipients, Essential Oils, and Aroma chemicals. - Strong skills in effective manpower handling and communication in English, both oral and written. This is a full-time position with benefits including Provident Fund. The work schedule is day shift, and the work location is in person.,

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 specifications. Additionally, maintaining quality records, site checklists, and NCRs, reporting deviations, proposing corrective actions, and ensuring project quality deliverables will be part of your role. To qualify for this position, you should have a B.E./B.Tech in Mechanical/Electrical/Instrumentation Engineering with a minimum of 5 years of relevant experience in QA/QC roles, preferably in Oil & Gas or EPC projects. You are expected to have a working knowledge of relevant codes, standards, and quality systems, familiarity with QMS documentation, ISO audits, and site safety practices, as well as excellent communication and reporting skills. If you meet the required skills and qualifications, you can apply directly or share your CV at hrd@spectron.in. For more information about SPECTRON Engineers Private Limited, visit www.spectron.in.,

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 documents for amendments, annual updates, regulatory filings, and CMC supporting documentation. Other tasks may include filling out questionnaires, declarations, quality agreements, and executing any additional responsibilities assigned by the Head of Department.,

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 and regulatory audits, as well as provide necessary documentation for amendments, annual updates, regulatory filings, and CMC supporting documentation. Your role will also involve filling out questionnaires, declarations, and quality agreements. Finally, you will execute any additional responsibilities assigned by the Head of Department.,

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 creating production plans on a monthly and daily basis according to material availability. Handling tasks such as change control, deviations, CAPA, investigations, and document management including BMRs, BPRs, and master SOPs will be part of your duties. You will also be involved in the preparation, review, revision, control, and implementation of standard operating procedures within the sterile manufacturing department. Conducting line clearance activities before commencing various operations such as manufacturing, sterilization, and filling, as well as checking and maintaining records and logbooks related to manufacturing processes, garment washing, drying, and equipment sterilization are key aspects of your role. Additionally, you will be required to perform any activities as instructed by the HOD, provide training to subordinates, technicians, and operators, and stay updated on self-hygiene practices. Attending training sessions as per the schedule and ensuring compliance with the Training Need Identification (TNI) will also be part of your responsibilities. Qualifications required for this role include M.Sc., B.Pharm, or M.Pharm degree.,

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 samples and their records. To maintain GMP in the plant and identify problem areas and report to Head-Quality. Line clearance in dispensing and production area. To perform in-process sampling, testing and document the observations. To handle IPQA activity in warehouse and production area.

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 Train & lead the Team Should be familiar with online GMP documentation. Should be familiar with Root cause Analysis tools. Should have in-depth knowledge on Equipment Qualification, Preventive maintenance documentation, ISO documentation, SAP knowledge. Responsible for preparation of SOP's, HVAC protocols and validation reports. Should be familiar with Change controls, Deviations, Risk assessments Should be familiar with process equipment like Reactor, centrifuge, ANFD, RCVD, Blender, sifter, multi mill, FBD etc Should be familiar with Utility equipment like Boiler, Air compressor, nitrogen plant, chillers Responsible for preparation of all types ofschedules and follow-up with user departments Responsible for Audit compliance, CAPA closing. Co-ordination with QA, production, EHS and Engineering team.