45 Apqr Jobs - Page 2

Must have experience of Vaccine/Biological Industry IPQA activity in Production BMR Review/ Line clearance Process Validation Media fill Validation Gowning Qualification/Visual inspector Qualification Trend/APQR preparation Investigation & Evaluation Dossier document compilation Job Location: Kadi, Gujarat ( Bus facility available from Ahmedabad, Kalol & Kadi) Note: Immediate joiners will be preferred first

Technical Documentation Must have documentation experience in COA, MSDS, VQ Filings, APQR, MOA, DMF, Stability data

Key Responsibilities: Lead and manage regulatory activities and documentation (individually and through a team). Ensure compliance with South Africa/country-specific guidelines. Review and peer-review regulatory submissions (electronic & non-electronic). Track and oversee project timelines and regulatory deliverables. Liaise with internal/external stakeholders to ensure timely documentation. Prepare/review APQR summary reports and implementation notifications. Stay updated on changing regulatory legislation. Guide and train internal teams on regulatory requirements. Ideal Candidate Profile: 6-9 years of experience in Regulatory Affairs. Strong knowledge of South African and/or international ...

Responsible for maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485:2016 and Local regulatory requirements (Indian Medical Device Rule). Responsible for internal audits, CAPA, change control, document control, risk management, and management review processes. Support external audits/inspections (Notified Body, regulatory, customer). Ensure compliance with applicable regulatory requirements and support quality system documentation updates. Collaborate with cross-functional teams to ensure quality and compliance across product lifecycle stages.

Review of BMR and other production and quality control related documents. Major experience in API IPQA activities (like: Plant rounding & monitoring). Preparation of APQR.

Retrival& Issuance of documentation GDP CGMP Control Documents Dispatch verification Batch Manufacturing

3+ years of hands-on CMC experience required with JMP for statistical analysis, including DoE(Design of experiment), statistical approaches: PCA, and PLS. Strong understanding of QbD, PQR, and regulatory guidelines (ICH/FDA) required. Proficiency in SAS/R programming is essential Software: Minitab and JMP

Role & responsibilities In-Process Monitoring : Monitor and evaluate the manufacturing or production processes in real-time to ensure compliance with quality standards and specifications. Sampling & Inspections : Conduct regular inspections, sampling, and testing of raw materials, in-process goods, and finished products to ensure quality control is maintained at every stage. Documentation & Reporting : Maintain accurate records of in-process quality checks, test results, and production data. Report any deviations, non-conformities, or issues to the production team and management. Training & Support : Provide guidance and training to production staff on quality standards, best practices, and ...

Job Description 1 Master & Control of all documents like SOPs, BMR, Specification & MOA, logbooks, calibration records to concern departments. 2 Issuance of all documents like SOPs, BMR, Specification & MOA, logbooks ,calibration records to concern departments 3 Preparation of all documents like SOPs, BMR, Specification & MOA, logbooks, calibration records of concern departments 4 Reviewing of HPTLC, TLC, GC reports, peaks, graphs etc 5 Checking & signing of BMR of Liquid syrup, Tablets & Mother tincture section. 6 Receipt & storage of executed documents like BMR, Analytical logbooks, calibration records etc. 7 Receipt & storage of control samples of finished product, raw material etc. 8 Rec...

Role & responsibilities The individual should be documenting Annual Product Quality Review (APQR): Collection of process and quality data for all products. The individual is capable for management of Retain Samples: Storage, maintain, visual inspection & destruction of Retain samples of all FG samples. Management of central document room/Documents: Issuance, Retrieval, Destruction & Control of all the GMP documents (eg: facility documents, Batch records, Protocols, Reports, etc.) Key competencies Skill Required/ Tools/ Software: The individual is responsible to work in compliant with Good Documentation Practice (GDP) and current Good Manufacturing Practice (cGMP). Interpersonal Skill: The in...

Oversee the entire quality assurance process, from raw materials to finished goods, ensuring consistent quality & compliance, ensuring that products meet regulatory requirements & quality standards like ISO 13485, ISO 9001, 21 CFR 211 & 21 CFR 820 Required Candidate profile Bachelors in science 10-15 years' experience in quality in medical device/ pharma industry QMS implementation experience Must have regulatory audit exposure Like WHO/ USFDA & EU GMP

Develop & update SOPs, ensure compliance, prepare MSDS/specs, review BMRs, check COAs/labels, maintain documentation, conduct training, perform audits, and support corrective actions to uphold quality standards across operations.

Desired Candidate Profile 2-5 years of experience in Quality Assurance & Compliance role in API manufacturing industry. MS/M.Sc(Science) degree in Chemistry Strong understanding of GMP & Regulatory Compliance, Document Control & SOP Management, APQR, CAPA & Market Complaint Management.

Preparation of Technical documents like below: COA/ Certificate of Analysis Specifications/ TDS Method of Analysis Stability Data DMF/ Drug Master File Declarations Preparation of Vendor Questionnaire Customer response for technical queries

Role & responsibilities You shall be responsible for maintaining and improving all QMS activity, GMP and GLP across the company. Key Deliverables: 1. Ensure manufacturing practices as per cGMP and GLP standards. 2. Handling QMS activities like change control, validations, stability, qualifications, APQR and Risk assessment etc. 3. Applications for AHC to AQCS, EIA and Capexil and coordinate related activities. (AHV/SPD: This is exclusive knowledge related to Capsule and companies manufacturing animal origin products. We have mentioned this as the candidate on joining will be responsible for this work though he/she may not be having exposure to same.) 4. Organize internal and external audits ...

Exciting Career Opportunity at Hetero (Annora Pharma) Pvt Ltd! We are conducting a MEGA Walk-in Drive @GOA for our Formulation Units in Hyderabad. If youre looking to grow your career in the pharmaceutical industry, dont miss this chance to join one of India’s leading pharma companies! Open Positions: 1. Production • Qualification: ITI / Diploma / B.Sc / B. Tech / B Pharm • Experience: 1–6 years • Designation: Operator / Jr. Officer / Officer / Jr. Executive / Executive • Areas: Granulation, Compression, Coating, FBP, QMS, Capsule filling 2. Quality Control • Qualification: M Pharm / B Pharm / MSc • Experience: 1–6 years • Designation: Jr. Officer / Officer / Jr. Executive / Executive • Area...

Vibonum Technologies Private Limited conducting a Walk-in interview in Quality Assurance department for its OSD Plant at Nanjangud, Mysore. Kindly carry your, latest 3 Months salary slip, appointment letter with CTC breakup and previous company relieving letters. ----------------------------------------------------------------------------------------------------------- Open vacancies in Quality Assurance for: IPQA Manufacturing : Exe > 08-10 Yrs IPQA Packing & Warehouse : Exp > 8 - 16 Yrs QMS: Exe / Sr. Exe : Exp > 08-10 Yrs CSV / ITQA/ Electronic DI compliance : Exp > 10-12 Yrs Process Validation : Exp > 08-10 Yrs AQA / Lab QA : Exp > 08-10 Yrs Documentation Cell : Exp > 04-08 Yrs AM/DM/Man...

Role & responsibilities Review of the executed manufacturing documentation at contractual partners and ensure its compliance with internal Quality Management System and applicable Regulatory Guidelines in cooperation with Quality Management at Krka. Reviewing the manufacturing documentation of pharmaceutical products and identifying potential errors or irregularities. Participates in investigation of deviations, complaints, unfavorable trends, and OOS results with contractual manufacturers. Participate in harmonization of applicable change controls. Takes part in organizing audits of our contractual partners in line with the audit plan and monitors its realization. Monitors the manufacturing...

Responsibilities: Initiation/Review of change control, impact assessment and management of change control records. Preparation of Annual Product Quality Review & MRM record. Review of Vendor questionnaire and related documents. Handling of deviation, market complaints, out of specification and CAPA. Review of Investigation of Deviation, OOS & Other Non-Conformities. Review Of Validation, Qualification CSV Document. interested candidates can share resume to hr3@sarthee.com or call at 9033033650

Ensure compliance with cGMP guidelines Batch Manufacturing Record preparation Packaging Material Specification Preparation APQR New drug application Batch card preparation Endorse documents preparation Required Candidate profile Experience in Quality Assurance of 5 years Gender Male