Process Validation - Quality Assurance - Unit III Unison Pharmaceuticals

4.0 - 9.0 years

4 - 9 Lacs

Ahmedabad

Work from Office

Excellent opening for Process Validation role in Quality Assurance in Unison Pharmaceuticals, Moraiya Company: Unison Pharmaceuticals Website: www.unisonpharmaceuticals.com Department: Quality Assurance Location: Unit III, Moraiya, Ahmedabad Designation : Process Validation: Executive/Sr. Executive Experience: 3-9 Years (In PV) Qualification: B.Pharm/M.Sc Job Description : Prepare process validation protocol and send for review, approval and authorization to concern team members Facilitate process validation training to production, QC and IPQA Collect samples from Granulation, Compression / Capsule filling and Coating stages and send to QC for analysis Perform required documentation activities like; utilization log and test request slip Compile data for each batch performed under validation stage Prepare process validation report post completion of the 3 validation batches and send the report for review and approval 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.

Posted 6 days ago

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QA Executive J B Chemicals & Pharmaceuticals Laboratories (JBCPL)

0.0 - 5.0 years

2 - 5 Lacs

Ankleshwar

Work from Office

Vacancy as per following 01. QA Officer / Executive : Required Candidates who have completed B.Pharm / M.Pharm for QA Department and must have experience of QMS and IPQA in Pharma formulation plant. 02. QA Officer / Executive : Required Candidates who have completed B.Pharm / M.Pharm / M.Sc. for QA Department and must have experience of QA in QC Dept. in Pharma formulation plant. 03. Production Officer / Executive : Required Candidates who have completed B.Pharm / M.Pharm for Production Manufacturing Department and must have experience of Production Dept. in Pharma formulation plant.

Posted 3 weeks ago

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Urgently Hiring For QA Validation - Green Field Project Amneal Pharmaceuticals

10 - 17 years

10 - 20 Lacs

Ahmedabad

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We are hiring for a Green Field Projects at Amneal , Ahmedabad. Following is the JD : Key Responsibilities : Lead QA operations related to Qualification & Validation, including Cleaning Validation, Process Performance Qualification (PPQ), and Computer System Validation (CSV). Develop and implement Validation Master Plans (VMP), Contamination Control Strategies, and Quality Risk Management (QRM) frameworks. Ensure qualification and validation of manufacturing equipment, utilities, and computerized systems to meet regulatory requirements. Drive regulatory inspection readiness, acting as SME for audits including USFDA, EMA, ANVISA, and WHO. Implement and optimize QMS using a risk-based approach, ensuring continuous monitoring and integration of compliance standards. Oversee execution of large-scale validation projects, such as Green Field Injectable facilities, and ensure regulatory approval readiness. Collaborate cross-functionally with Quality, Engineering, Production, and Regulatory Affairs teams for the successful and timely delivery of validation-related initiatives. Promote lean validation practices and continuous improvement strategies to enhance operational efficiency and regulatory compliance. Mentor, develop, and manage a high-performing QA validation team in a cross-cultural, fast-paced environment. Key Requirements : Education : Bachelors or Masters degree in Pharmacy, Chemistry, or related life sciences field. Experience : Minimum 15 years of experience in QA with strong specialization in Qualification & Validation within pharmaceutical manufacturing. Proven experience in injectable/sterile manufacturing environments is highly desirable. Hands-on experience in handling international regulatory audits and validations across FDA, EMA, and ANVISA-regulated markets. Technical Skills : Expertise in Cleaning Validation, PPQ, CSV, QRM, and VMP development. Strong command of GxP and global regulatory guidelines. Proficient in developing and managing QMS with focus on compliance and risk management. Leadership Skills : Demonstrated ability to lead cross-functional teams, influence stakeholders, and manage complex projects under tight timelines. Strong communication, decision-making, and coaching capabilities. Preferred Attributes : Green Field project experience, especially in injectables. Recognized as an SME in QA Validation. Familiarity with modern digital QA tools or systems is an added advantage. Interested candidate can share CV at bhuvneshwari.rathore@amneal.com

Posted 1 month ago

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