Sterile Injectable Manufacturing Specialist

2 days ago

Kurnool, Andhra Pradesh, India beBeeAsepticProcess Full time ₹ 25,00,000 - ₹ 40,00,000

Job Title:

Aseptic Process Specialist

About the Role:

Our organization is seeking a highly skilled Aseptic Process Specialist to ensure the quality of our sterile injectable products through various validation activities. This individual will be responsible for preparing, reviewing, and approving validation protocols and reports for media fill studies, ensuring aseptic process integrity.

Key Responsibilities:

  • Develop and implement aseptic process qualification protocols and reports to ensure compliance with regulatory requirements.
  • Analyze remote media fill results, identify deficiencies, and recommend corrective or preventive actions.
  • Prepare and review area qualification protocols and reports for classified manufacturing areas (Grade A–D) based on environmental monitoring and qualification data from the site.
  • Support and participate in Factory Acceptance Test (FAT) execution for equipment at vendor locations (onsite when required, otherwise through live remote connection), ensuring test protocols are followed and results are documented.
  • Collaborate with cross-functional teams to maintain and update the Validation Master Plan (VMP), ensuring alignment with regulatory expectations and site needs.

Requirements:

  • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
  • In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
  • Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.).
  • Strong analytical and problem-solving skills.
  • Effective communication and documentation skills.
  • Ability to manage multiple projects and prioritize tasks.

Preferred Qualifications:

  • 5-10 years of experience in Quality Assurance, preferably in sterile injectable manufacturing.

  • Senior Sterile Product Quality Assurance Specialist

    4 days ago

    Kurnool, Andhra Pradesh, India beBeeQuality Full time ₹ 30,00,000 - ₹ 50,00,000

    Job SummaryAs a quality assurance specialist, you will be responsible for reviewing and approving manufacturing records, ensuring compliance with regulatory requirements.Key ResponsibilitiesReview and approve executed batch manufacturing records and packaging records to ensure completeness, accuracy, and compliance with cGMP, SOPs, and regulatory...

  • Electronics Manufacturing Specialist

    6 days ago

    Kurnool, Andhra Pradesh, India beBeeSmt Full time ₹ 90,00,000 - ₹ 1,20,00,000

    Electronics Manufacturing SpecialistWe are seeking a skilled Electronics Manufacturing Specialist to provide technical support and lead defect analysis activities at our production facilities and customer sites.This role requires strong knowledge of SMT manufacturing processes, cellular module products, and problem-solving skills to work collaboratively with...

  • Manufacturing and Operations Specialist

    1 day ago

    Kurnool, Andhra Pradesh, India beBeeOperations Full time ₹ 6,00,000 - ₹ 10,00,000

    Manufacturing and Operations Professional">We are seeking a detail-oriented and proactive professional to join our team as a Manufacturing and Operations Specialist. The ideal candidate will have expertise in process optimization, supplier negotiations, and lean manufacturing. This position involves working alongside experienced professionals to contribute...

  • Senior Medical Device Specialist

    4 days ago

    Kurnool, Andhra Pradesh, India beBeeMedical Full time ₹ 20,00,000 - ₹ 25,00,000

    Job Title: Senior Medical Device SpecialistWe are seeking a highly experienced Senior Medical Device Specialist to lead our medical device assessment and auditing initiatives. This role involves ensuring compliance with regulatory requirements across various jurisdictions.Key Responsibilities:Evaluate medical devices for conformity to ISO 13485, MDD...

  • Senior Manufacturing Operations Manager

    3 days ago

    Kurnool, Andhra Pradesh, India beBeeQuality Full time ₹ 18,00,000 - ₹ 25,00,000

    Production Operations ManagerThe role of the Production Operations Manager is pivotal in ensuring smooth production operations and meeting operational goals. As a key member of the team, the incumbent oversees daily activities, manages staff, optimizes processes, and ensures quality management systems are upheld to high standards.Key Responsibilities:Develop...

  • Pharmaceutical Manufacturing Professional

    2 days ago

    Kurnool, Andhra Pradesh, India beBeeQuality Full time ₹ 15,00,000 - ₹ 25,00,000

    Quality Assurance SpecialistWe are seeking a highly skilled Quality Assurance specialist to join our organisation. This role is responsible for ensuring line clearance, material verification, and conducting in-process checks according to batch manufacturing and packing records.Key Responsibilities:Performing line clearance, material verification, start-up...

  • Quality Assurance Compliance Professional

    1 week ago

    Kurnool, Andhra Pradesh, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,01,00,000

    Job SummaryWe are seeking a Quality Assurance Compliance Specialist to join our team. As a Quality Assurance Compliance Specialist, you will play a key role in ensuring that our products meet the highest standards of quality and compliance.Responsibilities:Prepare and review QMS-related documents, including SOPs, work instructions, and templates for...

  • Electronics Manufacturing Specialist

    1 day ago

    Kurnool, Andhra Pradesh, India beBeeManufacturing Full time US$ 30,000 - US$ 60,000

    Electronics Manufacturing ExpertWe are seeking a highly skilled and experienced Electronics Manufacturing Expert to join our team. The ideal candidate will have a strong background in electronics manufacturing, with expertise in SMT and Through-hole production.Key Responsibilities:Oversee the production process, ensuring timely delivery and high-quality...

  • Healthcare Specialist

    5 days ago

    Kurnool, Andhra Pradesh, India beBeePerioperative Full time ₹ 9,00,000 - ₹ 12,00,000

    Job Overview">We are seeking an experienced and skilled perioperative nurse to fill this key role in our healthcare team. The successful candidate will be responsible for preparing operating rooms, assisting surgeons during surgeries, and ensuring the sterility and functionality of medical instruments.">Key Responsibilities:">Prepare operating rooms for...

  • Ammunition Manufacturing Quality Assurance Professional

    1 day ago

    Kurnool, Andhra Pradesh, India beBeeQuality Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Quality Assurance SpecialistAbout the Role:We are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will be responsible for ensuring that our ammunition manufacturing processes meet the highest standards of quality.Key Responsibilities:Develop and Implement Quality Control...