Officer, Quality Assurance

4 days ago

Vizag, Andhra Pradesh, India Amneal Full time ₹ 5,00,000 - ₹ 15,00,000 per year
Description
Job Description

The IPQA professional will be responsible for monitoring in-process quality checks in the manufacturing area (API) to ensure compliance with cGMP, SOPs, and regulatory requirements. The role involves real-time verification of manufacturing activities, documentation review, and effective communication with production and QA teams

Key Responsibilities

Ensure adherence to cGMP and GDP practices during all in-process activities.

Perform line clearance checks before starting production and packaging operations.

Monitor and verify critical manufacturing and packaging parameters as per approved BMR/BPR.

Review and ensure compliance with SOPs, protocols, and regulatory guidelines.

Verify sampling, labeling, and dispensing of raw materials and intermediates.

Perform in-process checks and record observations in real-time.

Ensure timely identification, documentation, and escalation of any deviations, OOS, OOT, or incidents.

Support QA team in investigations and CAPA implementation.

Participate in internal audits, regulatory inspections, and compliance activities.

Maintain effective communication with Production, QC, and QA teams for smooth operations.

Ensure that all activities are performed safely and in accordance with company policies.

Skills & Competencies

Strong knowledge of cGMP, GDP, and regulatory compliance.

Hands-on experience in API manufacturing processes.

Good understanding of QA/QC procedures.

Strong communication and interpersonal skills for cross-functional coordination.

Documentation accuracy and attention to detail.

Ability to work in a fast-paced manufacturing environment.

Qualifications

Qualification: M.Sc. (Chemistry/Pharmaceutical Sciences)
Experience: 2 to 4 Years (API industry experience mandatory)

Additional Responsibilities

Conduct periodic shop floor rounds to ensure compliance with cGMP and safety practices.

Provide on-the-job training to production personnel on documentation and quality practices.

Support preparation and review of SOPs, protocols, and batch records.

Monitor and control environmental conditions in production areas (temperature, pressure differentials, cleanliness).

Ensure timely closure of deviations, CAPA, and change controls related to IPQA activities.

Support technology transfer and validation activities from a QA perspective.

Assist in review of batch manufacturing records (BMR) and batch packaging records (BPR) for completeness and compliance.

Act as QA representative during regulatory and customer audits.

Contribute to continuous improvement initiatives in QA and manufacturing processes.

  • Associate Manufacturing Quality Assurance

    1 week ago

    Vizag, Andhra Pradesh, India Pfizer Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Role SummaryManufacturing Quality Downstream Associate is responsible for primary contact of quality on the floor, particularly in the Terminal sterilization, Visual Inspection and Packing areas of production and monitor processes for compliance to cGMP standards.ResponsibilitiesResponsible for ensuring operating state of cGMP compliance in Terminal...

  • Officer, Quality Assurance

    4 days ago

    Vizag, Andhra Pradesh, India Amneal Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    DescriptionJob DescriptionThis role involves monitoring in-process quality checks in the manufacturing area (API) to ensure compliance with cGMP, SOPs, and regulatory requirements. The role involves real-time verification of manufacturing activities, documentation review, and effective communication with production and QA teamsKey ResponsibilitiesEnsure...

  • Quality Assurance Consultant L1

    2 weeks ago

    Vizag, Andhra Pradesh, India Wipro Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Job DescriptionJob Title: Quality Assurance Consultant L1Req Id: 112476City: VisakhapatnamState/Province: Andhra PradeshPosting Start Date: 11/18/25Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading technology services and consulting company focused on building innovative solutions that address clients' most complex digital transformation needs....

  • Associate Manager- Quality Assurance

    1 day ago

    Vizag, Andhra Pradesh, India Pfizer Full time

    Use Your Power for PurposeEvery day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your...

  • Quality Engineer

    16 hours ago

    Vizag, Andhra Pradesh, India GAURAV ENTERPRISES Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Company DescriptionGAURAV ENTERPRISES, established in 2010, is a leading Railway Track Construction company specializing in turnkey rail infrastructure projects. With expertise in Railway Track Construction, Information Systems, and Annual Maintenance Contracts, the company serves projects across India, including Metro rail systems. Known for its adherence...

  • Associate- Quality Systems

    6 days ago

    Vizag, Andhra Pradesh, India Pfizer Full time ₹ 6,00,000 - ₹ 8,00,000 per year

    Use Your Power for PurposeEvery day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your...

  • Associate- Quality Systems

    6 days ago

    Vizag, Andhra Pradesh, India Pfizer Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Use Your Power for PurposeEvery day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your...

  • Associate Manager-Quality Investigation

    3 days ago

    Vizag, Andhra Pradesh, India Pfizer Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Use Your Power for PurposeEvery day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through...

  • Front Office Executive

    6 days ago

    Vizag, Andhra Pradesh, India Starlite Wellness Full time ₹ 4,00,000 - ₹ 6,00,000 per year

    Company DescriptionEstablished in 2016, Starlite is dedicated to integrated health and holistic wellness. Our philosophy centers around client care, viewing holistic healing through the mind, body, and spirit. Our team of nutrition and wellness consultants enhances clients' quality of life through personalized health approaches. We are committed to research,...

  • Front Office Associate

    2 weeks ago

    Vizag, Andhra Pradesh, India SUNRAY RESORTS PRIVATE LIMITED Full time ₹ 2,00,000 - ₹ 2,50,000 per year

    Company DescriptionSUNRAY RESORTS PRIVATE LIMITED is a hospitality company headquartered in Visakhapatnam, Andhra Pradesh, India. The company operates from its base at , Ground Floor, Excelsior Apartments, opposite Lions Club in Ram Nagar. SUNRAY RESORTS is dedicated to providing exceptional guest experiences, blending comfort and quality service. The...