QA/QC job vacancy at Jammu in Vivek Pharmaceutical Pvt Ltd

Job Title: QA Manager
Industry: Pharmaceutical & Life Sciences
Department: Quality Assurance
Role Category: Production & Manufacturing
Employment Type: Full Time, Permanent
Experience Required: 15-25 Years
Education Required:
• UG: B.Pharma (Any Specialization)
• Preferred Post-Graduation Qualification: Quality Assurance, Pharmacy, or (M .Pharma)
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Role & Responsibilities:
As a QA Manager, you will lead the Quality function across multiple departments, including Quality Assurance (QA), Quality Control (QC), and Microbiology. This critical role ensures that manufacturing operations are fully compliant with international regulations and consistently meet high-quality standards. You will drive continuous improvement initiatives, manage audits, and oversee the development and implementation of strategies to enhance product quality.
Key Responsibilities:
• Leadership & Quality Culture:
Lead, mentor, and inspire the Quality teams, promoting a culture of quality across the organization. Ensure audit readiness at all times and foster a proactive, quality-driven environment.
• Regulatory Compliance & Audits:
Ensure strict adherence to international regulatory requirements such as WHO GHP, Revised Schedule M, and other relevant standards. Manage successful audit outcomes to maintain compliance.
• Manufacturing Operations:
Oversee cGMP-compliant operations, focusing on the production of Oral Solid Dosage (OSD), Small Volume Parenteral (SVP), Beta Lactam, and External Preparations. Manage scale-up processes, new product development, and product lifecycle.
• SOPs & Documentation:
Ensure all Standard Operating Procedures (SOPs) align with WHO GHP, Revised Schedule M, and regulatory guidelines. Work closely with cross-functional teams on new product registrations and updates.
• Quality Management Systems (QMS) & Continuous Improvement:
Strengthen and enhance the QMS across the organization. Drive continuous improvement initiatives, ensuring that quality is maintained and improved at all levels of operation.
• Risk Management & Compliance:
Conduct regular compliance reviews, facilitate facility and equipment qualifications, and manage quality risk assessments to mitigate potential risks to product quality.
• Dossier Filing for Exports:
Oversee and manage the preparation and filing of dossiers for export markets, ensuring that all documentation meets regulatory and quality standards.
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Key Skills & Experience:
• Experience in Regulated Environments:
Extensive experience in manufacturing environments, particularly in the production of injectable products, with a deep understanding of regulatory standards and compliance processes.
• Audit & Compliance Management:
Strong background in audit management, ensuring successful audit outcomes while maintaining the highest standards of compliance.
• Leadership & Team Management:
Proven leadership ability to manage cross-functional teams, mentor staff, and build a cohesive and effective Quality function.
• Analytical & Negotiation Skills:
Strong analytical skills to assess compliance and quality issues, with the ability to negotiate and resolve challenges effectively.
Communication & Collaboration:
Excellent verbal and written communication skills, with the ability to collaborate effectively with internal teams and ________________________________________
Preferred Candidate Profile:
• Education:
Bachelor's degree in Pharmacy, Science, or related field. Post-graduate qualification in Quality Assurance is preferred.
• Core Competencies:
Strong leadership and mentoring capabilities, exceptional communication skills, attention to detail, and the ability to drive process improvements.
• Experience:
15-25 years of experience in the pharmaceutical industry, particularly in Quality Assurance and regulatory compliance.
• Travel Flexibility:
Open to travel up to 50% of the time, managing various scheduling requirements across different sites.
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