42 Cleaning Validation Jobs - Page 2

Handling of Equipment Qualification, Area Validation, Process validation, cleaning validation, Risk assessment, Change control, Deviation, HVAC validation please share your profile & contact: Call: 8160615349/7878051751

In-Process Monitoring, Documentation, Quality Inspections, Non-Conformance Handling, Compliance, Collaboration, BMR, BPR, Compliance, Collaboration, Basic understanding of quality assurance processes, Knowledge of GMP and ISO standards 9313198637

Department - Quality Assurance Designation - Officer ( Vendor Qualification) No. Of Vacancy - 1 (Male) Qualification B. Pharm / M. Pharm Required Experience - 1 3 Years Industry - Pharma (Formulation) Key Roles ( As per JD) Review of stability related to quality control. Review of SOPs and internal calibration records. CAPA verification related to quality control units. To perform the risk assessment of the quality control and plan the mitigation in coordination to quality head. Department - Quality Assurance Designation - Officer ( IPQA) No. Of Vacancy - 9 (8 Male, 1 Female) Qualification - B.Pharm / M. Pharm / M.Sc Required Experience - 1 - 3 Years Key Roles ( As per JD) Procedure and verify incoming Raw Materials as per approved vendors, clean area environment monitoring data, reconciliation of the rejections at filling, sterilization and packing stage, prepare and perform visual inspection, documentation (batch records, Logbooks) Regards, Darshana cv.naukri@evokehr.com

Role & responsibilities 1. Reporting to reporting manager and assist him in Quality Assurance activities. 2. Responsible for IPQA activities. 3. Responsible for giving Line clearance to Equipment/Area. 4. Responsible for monitoring packing and repacking of API and intermediates as per BPR and PO. 5. Responsible to Plant round for online compliance. 6. Responsible for review of batch manufacturing sheets. 7. Responsible for Review of the batch release documentation. 8. Responsible for supporting to customers, regulatory audits. 9. Responsible for Preparing & Reviewing of quality system related documents like SOPs, BMS, Formats, registers, compilation of validation protocol and reports etc. 10. Documents Control and Issuance i.e., SOPs, BMS, Formats, registers, specifications and Method of analysis, compilation of validation protocol and reports etc. 11. Responsible for Preparation & review of Annual product review (APQR). 12. Responsible for Preparation & review of Validation protocol and reports. 12. Additionally, responsible for to carry out any work assigned or delegated by HOD/Designee Quality Assurance

We are seeking a highly motivated and detail-oriented QA Executive to join our team. The ideal candidate will have a strong background in the pharmaceutical, API, or chemical industry with hands-on experience in quality assurance activities. This position requires a keen eye for detail, the ability to work efficiently under pressure, and a commitment to maintaining the highest standards of quality. Key Responsibilities: Document Management: Manage and control the issuance and reconciliation of essential quality documents including BMR, ECR, BPR, SOPs, Logbooks, and Labels. Quality Systems: Perform tasks related to VQ (Validation Qualification), change control, deviation management, market complaints, and DMF readiness. Audit Readiness: Ensure that all documentation and processes are in place for successful audit outcomes and maintain compliance with regulatory requirements. Process Validation: Work closely with the process validation team to ensure that all processes meet required specifications. GMP Compliance: Maintain and ensure daily GMP (Good Manufacturing Practices) formats are followed across operations. Team Collaboration: Collaborate with other departments to support continuous improvement initiatives and maintain the quality of products in production. Required Qualifications & Skills: Education: BSc/MSc/B Pharm/M Pharm (Chemistry/Microbiology/Any other related field). Experience: Minimum of 2-3 years of experience in the pharmaceutical API, intermediate, or chemical industry. Skills: In-depth knowledge of document issuance and control (BMR, ECR, BPR, SOPs). Hands-on experience in VQ, change control, deviation management, and market complaint handling. Experience with audit readiness and process validation. Strong understanding of GMP compliance and daily GMP formats. Excellent teamwork and collaboration skills.

experience in Validation activities (Equipment Qualification, Autoclave Qualification, HVAC Qualification, Smoke Studies, Cleaning Validation etc.). Plus sterile experience is required. Required Candidate profile experience in Validation activities (Equipment Qualification, Autoclave Qualification, HVAC Qualification, Smoke Studies, Cleaning Validation etc.). Plus sterile experience is required.

We are looking for a highly skilled CQV Engineer to support commissioning, qualification, and validation (CQV) activities for Injectable and Biologics Process Equipment , HVAC, Utility Systems , and pharmaceutical manufacturing processes. The ideal candidate should have experience in validation lifecycle, equipment qualification, risk assessments, and GMP compliance , with strong expertise in document review and execution . Key Responsibilities: Develop and execute CQV documentation such as CQMP, VMP, FRA, cGMP review sheets, and interdependencies . Prepare and execute qualification protocols ( IQ, OQ, PQ ), SOPs, process validation, and cleaning validation protocols . Perform risk assessments (SCA/SLIA, CLIA, SRA/QRA) and ensure compliance with cGMP regulations . Conduct commissioning and validation activities for Injectables, Biologics, API, Fill/Finish, and OSD pharmaceutical process equipment . Perform HVAC and Utility Systems commissioning and qualification . Work with process equipment including PFS, Cartridge, Vial, Isolators, Lyophilizer, Inspection Lines, and Packing Lines . Review, analyze, and interpret system performance data , preparing final report packages . Handle deviations, discrepancies, investigations, CAPA , and ensure ALCOA principles are followed. Ensure compliance with regulatory requirements , including GDP practices . Draft and review equipment operation SOPs and validation-related documentation. Utilize ValGenesis software for qualification activities (preferred). Work collaboratively within project teams and interact with regulatory bodies as needed. Required Qualifications & Skills: Bachelors/Masters degree in Chemical/Pharmaceutical Engineering or related field. 4-10 years of experience in validation, quality systems, or engineering in a GMP environment . Strong expertise in Injectable and Biologics Process Equipment validation, HVAC & Utility Systems commissioning . Hands-on experience with equipment qualification and commissioning protocols . Experience with validation lifecycle approach , risk-based validation methodologies , and regulatory compliance (FDA, EU GMP, WHO) . Knowledge of Documentum or Maximo (preferred). Strong analytical, documentation, and communication skills. Proficiency in Microsoft Office tools. Willingness to travel internationally with a valid passport (no legal restrictions).

CANDIDATES HAVING EXPERIENCE IN EXTERNAL / TOPICAL PREPRATIONS (Ointment, Creams, Gels) WILL BE GIVEN PREFERENCE. Key Responsibilities: Review and verify quality-related documents and procedures. Handle change control, deviations, and impact assessments. Manage incidents, investigations, and CAPA implementation. Oversee market complaints, product recalls, and mock recalls. Prepare and review SOPs, validation protocols, and reports. Ensure compliance with batch manufacturing and packing records. Monitor shop floor activities for quality assurance. Implement and manage quality control processes. Perform other tasks as assigned by management. Preferred candidate profile Required Qualification: - B.Pharma/M.Pharma Industry : Pharmaceutical Formulation/API Experience: 06 - 11 Years Role: Sr.Officer/Executive Department: Quality Assurance Employment Type: Full Time, Permanent CTC: Will depend on Current CTC & Interview Performance.

Role & responsibilities Has Experience of Validation process . Experience of Process Validation Experience of Cleaning Validation Hands on experience of Creating and reviewing Protocol for Validation Preferred candidate profile Profile - Validation Total Experience - 3+ to 5 Yrs Qualification - Msc Chemistry

Role & responsibilities: To handle cleaning validation activities. (MACO calculation, product and equipment matrix preparation, grouping, sampling location/ analytical method updating in software as well as manually. Preparation of cleaning validation, cleaning verification, cleaning study protocols and report compilation. Evaluation of newly introduced equipment/product with respect to cleaning validation master plan (Bracketing) for cleaning validation and cleaning verification requirements. Various cleaning study execution with respect to change in cleaning agent/cleaning procedure. Annual Cleaning process review report preparation for evaluation of cleaning process/ Change Control/ Deviation/ New product introduction/ New equipment introduction not limited to. Protocol preparation, execution and report compilation of DEHT/CEHT/recovery study for various equipment and to evaluate gap assessment in cleaning validation SOP. To support Process validation and Hold time study activities Execution in duct cleaning validation/ verification activities with CFT Identification of Hard to clean locations of equipment with production team. Identification of worst case products and calculation of swab limits. Determination of Visual residue limit by protocol based study. To involve in investigations / failures related to cleaning methodologies. Preferred candidate profile: Well-versed with Cleaning Validation activities in OSD mfg. site. Sharp in Documentation and Review of shopfloor data Good communication and interpersonal skills EU/ TGA/ ANVISA regulatory audit exposure is an advantage Good knowledge of European agency guidelines Sound knowledge of ALCOA+ concepts and able to identify gaps w.r.t. ALCOA+ principles if any at shopfloor operations. Strong analytical and problem-solving skills Attention to detail and ability to work under pressure Knowledge of the local language (Kannada) is an added advantage Perks and benefits: Best in industry

Department : Quality Assurance Key Responsibilities : Process Validation : Plan, execute, and document process validation activities in compliance with regulatory requirements and internal SOPs. Ensure adherence to protocols and identify critical parameters affecting product quality. Cleaning Validation : Develop and implement cleaning validation strategies for equipment and facilities. Monitor and evaluate cleaning effectiveness and ensure compliance with established standards. Prepare cleaning validation reports and address deviations. Hold Time Studies : Conduct hold time studies for raw materials, intermediates, and finished products. Analyze data and establish appropriate hold times to maintain product quality. Aseptic Process Simulation (Media Fill) : Plan and execute aseptic process simulations using media fills to validate aseptic techniques. Monitor critical control points and ensure compliance with cGMP and regulatory standards. Document and report findings and address any non-conformances. Visual Inspection and Inspector Validation : Validate visual inspection processes to ensure defect detection and product integrity. Train and qualify visual inspectors in accordance with established protocols. Conduct routine audits of visual inspection processes to maintain consistency and accuracy. Qualifications and Skills : Education : Bachelor's/Master's degree in Pharmacy, Microbiology, Chemistry, or a related field. Experience : 3-4 years of relevant experience in Quality Assurance in the pharmaceutical or biopharmaceutical industry.

CQA Deputy Manager Domnic Lewis has been mandated to hire forCQA Deputy Manager Key Responsibilities : Conduct Vendor Audits for Raw Materials and Packaging Materials. Plan and prepare the vendor audit schedule; coordinate with the Purchase team for efficient execution. Review and evaluate vendor qualification documents, including Vendor Questionnaires, Audit Reports, Quality Agreements, DMF, and all related declarations. Address and resolve regulatory queries as required. Present Vendor Qualification Documentation and Systems during Regulatory Inspections and Customer Audits at the manufacturing sites. Support investigation of market complaints and track CAPA (Corrective and Preventive Actions). Required Skills : Strong knowledge of current regulatory requirements. Familiarity with Good Warehouse Practices (GWP) and Good Distribution Practices (GDP). Proficient in Microsoft Office Suite, Excel, SAP, and Document Management Systems (DMS). Excellent communication, listening, and managerial skills. Willingness to travel as required. Qualifications : B. Pharm, M. Pharm, or M. Sc. in a relevant field. Experience : Minimum 9-12 years of experience in Quality Assurance, with a focus on vendor qualification and regulatory compliance.

Responsible perform/Report the analysis of Water and pure steam (Condensate) samples. Responsible for preparation of Standard operating procedures, Standard test procedures, specifications ,SOP, STP, Specification, ATDS CoA of the RM, PM, Consumable Required Candidate profile change control /deviation / OOS / OOT / OOC/CAPA. Analytical method transfer/Stability Protocols Report the analysis of Finished Product, In- IP, SFG, FP. Perform the analysis as or when required

To review validation master plan of the plant and comply with the validation requirements of various regulatory authorities and customers. To review the process validation/ cleaning validation qualification protocols. To review SOPs, batch manufacturing and packing records, specifications, and test methods of the products. To monitor, control and review deviations, change controls, out of specifications may occur at all stages of storage, dispensing, manufacturing, packing, testing and distribution. To ensure issuance, control, distribution, storage, retention and destruction of quality documents and corporate guidelines as per Food safety Quality management system. To ensure that all critical equipment and utilities that are used to manufacture the product are under qualified status, calibrated and are under routine preventive maintenance program. To ensure proper investigation of market / customer / regulatory complaint by root cause analysis, corrective actions and ensure effective implementation of CAPA initiatives, close the complaints, send responses to the complainants, and verify effectiveness of CAPA periodically. To evaluate batch records, COAs and release finished products for sale. To ensure that, all the operations are carried out are as per GMP and laid down procedures, that each production batch complies with the provisions of Food safety standards (FSS) act and other legal, customer and regulatory requirements. To ensure compliance to the regulatory, customer, legal requirements and face audits and comply non-conformities observed during the audits. To ensure compliance to the current ISO 9001, DC Act, FSS Act 2006, FSSC 22000 (including HACCP), FAMI-QS, WHO-GMP and other customer and regulatory requirements. To carry out self inspections and ensure compliance to the audit observations of manufacturing, testing, warehousing facility. To ensure completion of APRs of products and take appropriate actions in case of deviations. Recommendation to recall approving authority on product recall, review, and disposition of recalled and returned goods. Handling of online and in process rejections and take appropriate actions to avoid the recurrences and disposition. To co-ordinate with CQA for up gradation in the SAP systems as per any changes or new product at Mahad site. To monitor stability of products, control sample storage and compilation of analytical reports and take appropriate action in case of failures. To identify and provide resources with co-ordination with other departments to carry out quality functions effectively. To liaison with regulatory authority for new product permissions, licenses and renewals, certificates, and approvals. Ensuring implementation and execution requirements of food regulations for export market (US)-21 CFR Part 110 111. Ensuring avoidance of breach of data integrity at all the levels. Ensuring implementation of effective sanitation activities at all the levels. Imparting required training to shop floor personnel. Adherence to the requirements of EHS norms. To raise the PR for procurement of miscellaneous items, external trainings, certification fees and capex related items. To sign the Excess Material Requisition, LRA notes, BMR return notes and other QMS documents in absence of Head- QA. To perform MSC2N transactions in SAP. Review of Change Control, Deviation, CAPA in trackwise. Implementation and execution of various initiatives as are suggested by corporate functions (SEEDS, Learning university, Quality mindset). SOP, BMR/BPR, layouts, STP review and approval in ENSUR system. To conduct vendor audits for RM/PM. To lead and guide the IPQA team for shopfloor activities. To set, review and evaluate KRA of reportee s. To share the RR nominations of team members on quarterly basis. To identify and implement the OE projects. Patient/ Customer centricity. B. Pharm/ M. Pharm

About Us: Unison Pharmaceuticals Private Limited (Formerly known as Unison Pharmaceuticals) was established in 1981 with a vision of providing quality & most affordable medicines across the nation. The company is having 1st Rank (Unit wise sales) in Gujarat state since more than 17 consecutive years as per ORG IMS. In addition to this, the company is ranked 82 among top companies of India (Rupee wise sales) MAT December 2021. Website : www.unisonpharmaceuticals.com We are seeking specialists for multiple roles into Quality Assurance at our EU Approved OSD Manufacturing facility at Unit I Moraiya, Ahmedabad. Company : Unison Pharmaceuticals pvt ltd. Location : Unit I (Moraiya, Ahmedabad) - Transportation provided from Ahmedabad routes (1) Quality Assurance - Validation Designation: Sr. Executive /Assistant Manager /Dy. Manager Education Qualification: B.Pharm/M.Sc/M.Pharm Experience Required: 8 to 12 years Job Exposure required: Must Have : Process Validation, Cleaning Validation Preferred to have: QMS, Risk Management, Qualification (2) Quality Assurance - Compliance & Training Management Designation: Executive / Sr. Executive Education Qualification: B.Pharm/M.Sc/M.Pharm Experience Required: 6 to 10 years Job Exposure required: Must Have : Audit Compliance, Training Management (3) Quality Assurance - Documentation Designation: Officer / Sr. Officer / Executive Education Qualification: B.Pharm/M.Sc/M.Pharm/B.Sc Experience Required: 4 to 7 Years Job Exposure required: Must Have : APQR or IPQA & Batch Record Preparation (4) Quality Assurance - Process Validation Designation: Officer / Sr. Officer / Executive Education Qualification: B.Pharm/M.Sc/M.Pharm/B.Sc Experience Required: 5 to 8 Years Job Exposure required: Must Have : Process Validation, Hold Time Study (5) Quality Assurance - IPQA - Packing Designation: Officer / Sr. Officer / Executive Education Qualification: B.Pharm/M.Sc/M.Pharm/B.Sc Experience Required: 4 to 8 Years Job Exposure required: Must Have : In process QA , Line clearance of Packing area Perks & Benefits Dynamic work environment Career development opportunities Work-life balance Free transportation Free insurance coverage for self, spouse, and kids Range of learning opportunities to help employees grow and thrive If you are passionate about continuing to work in the pharmaceutical industry and possess the required skills, we encourage you to apply for this position. Please submit your resume to career@unisonpharmaceuticals.com to be considered for this role. Join our team at Unison Pharmaceuticals and take the first step towards a rewarding career.

Designation- Officer/ Sr. Officer- Quality Assurance (API) Location:- Dahej Qualification:- MSc / B.Pharm/ M.Pharm Experience:- 2-5 years of experience into QMS, AQA, Computer system Validation, RA, IPQA & Cleaning Validation

To prepare & review Validation Master Plan(VMP), Qualification Master Plan (QMP) & Computer System Validation Master Plan(CSVMP) To follow the validation master plan To prepare & review Qualification & Validation Documents & execution as per protocol Required Candidate profile To update equipment & utility periodic requalification/re-verification schedules on monthly basis.Handling & storage of all quality document like BMR, BPR, log book,Protocol&SOP throughout life cycle.