No longer accepting applications

▷ Apply in 3 Minutes! Head Sterile Quality Compliance

Immacule LifesciencesIndia

8 hours ago

Job description

Responsible for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at site

Conduct sterile quality management review periodically

Periodic review and routine check of classified areas like manufacturing, Microbiology and utility areas

Preparation & adherence to Sterility Assurance Calendar consisting of Review timelines, training calendar and requalification

Ensuring SOP adherence to clean room facility / utilities / equipment / Personnel qualifications whichever has a potential to impact the Sterility of the product.

Review validation / protocol studies which has potential to directly or indirectly impact the sterility of the product

Oversee the media fill program

Oversee the microbial OOS and OOT investigations, ensure microbial excursions are adequately handled and investigated

Ensure microbial trend data is analyzed and actions are taken proactively.

Environmental Monitoring (EM)

Personnel Monitoring

Media Fill Simulations (Process Simulations)

Change controls related to Facility / Process / Utilities which may impact the current validated state with a focus on Sterility

Ensuring periodic training of personnel involved in Sterility process and ensure practices to be followed while ensuring desired behavior on shop floor

Ensure the microbial testing at the laboratory meets the appropriate guidance and pharmacopeia

Ensure the microbial data generated in laboratory is used meaningfully for plant operations

Oversight of aseptic interventions, gowning qualifications, and contamination control strategies

Ensure appropriate Data Integrity controls are applied and followed

Create a job alert for this search

▷ Apply in 3 Minutes! Head Sterile Quality Compliance • India

Related jobs

Promoted

Site Quality Head

Knovea Pharmaceutical Private LimitedIndia

Department : Quality Designation : General Manager / Sr.General Manager Educational Qualification : B.Pharma Experience required : 20 years to 25 years. Job Description : Responsible for management of al...Show moreLast updated: 1 day ago

Promoted

Head of Quality Control [Immediate Start]

TaggdIndia

Accountabilities & Responsibilities.Strategic QA / QC Leadership & System Development.Develop, implement, and maintain a comprehensive Project Quality Management System (PQMS) in accordance with inte...Show moreLast updated: 9 days ago

Promoted

Head Sterile Quality Compliance

Immacule LifesciencesIndia

Responsible for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at site Conduct sterile quality management review ...Show moreLast updated: 11 days ago

Promoted

SAP PP / QM Consultant – Pharma Industry | India

DecskillNagpur, IN

IT Consulting Company and their main mission is to delivery value through the knowledge.We enable companies to meet the chalenges of digital world by providing our clients with business models that...Show moreLast updated: 30+ days ago

Promoted
New!

Compliance Engineer - Safety and Quality Compliance (Remote)

CertivoIndia, India

Remote

Certivo is an AI-first platform that assembles, validates, and keeps regulatory.We turn messy supplier documents into.You’ll be the company’s point of truth for. Your work directly determines whethe...Show moreLast updated: 18 hours ago

Promoted

Compliance Specialist

Sycamore Informatics Inc.Nagpur, IN

Assist with Quality System development, training, and process.Assist with internal audits to assess compliance.Represent or assist SI in external audits. Participate in the CAPA process.Assist and w...Show moreLast updated: 11 days ago

Promoted
New!

▷ 3 Days Left : Head of Quality and Regulatory Compliance

GetingeIndia

The Director of QRC, IN will serve as an active member of the Global Sales (GS) SAPAC region QRC leadership and IN SSU Leadership Teams, on top of the role as IN SSU Management Representative.He / S...Show moreLast updated: 4 hours ago

Promoted

Compliance Engineer - Sustainability Compliance (Remote)

CertivoNagpur, IN

Remote

Certivo turns regulatory evidence into market access.Our AI, CORA, automates supplier outreach, data extraction, and rule checks, then assembles market-ready packets mapped to every product × site ...Show moreLast updated: 1 day ago

Promoted

Lead Regional Compliance Specialist

Securitas GroupNagpur, IN

Lead Regional Compliance Specialist - APAC.India – open to Chennai / Hyderabad / Pune.We are a dynamic, dedicated team that provides management and support for a global guarding services account that s...Show moreLast updated: 30+ days ago

Promoted

Head of Quality and Regulatory Compliance

GetingeIndia

Job Overview : The Director of QRC, IN will serve as an active member of the Global Sales (GS) SAPAC region QRC leadership and IN SSU Leadership Teams, on top of the role as IN SSU Management Repres...Show moreLast updated: 30+ days ago

Promoted
New!

3 Days Left : Head Sterile Quality Compliance

Immacule LifesciencesIndia

Responsible for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at site - Conduct sterile quality management revie...Show moreLast updated: less than 1 hour ago

Promoted

▷ Apply Now! Manager – Sterile Micro / EM Compliance

Immacule LifesciencesIndia

Ensure and assist the Head Sterile Quality Compliance for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at the m...Show moreLast updated: 6 days ago

Promoted

Regulatory Compliance Specialist -2+

Jupiter AI LabsNagpur, IN

Regulatory & Compliance Specialist.India and international destination countries.This role is ideal for professionals experienced in handling regulatory filings, certifications, and export-related ...Show moreLast updated: 26 days ago

Promoted

Quality Assurance (QA) Consultant - 4+

Jupiter AI LabsNagpur, IN

We are looking for an experienced.The role involves close coordination with accredited labs, suppliers, and internal teams to ensure compliance with quality standards and regulatory requirements.CO...Show moreLast updated: 26 days ago

Promoted

Quality Assurance Engineer

Synthio LabsNagpur, IN

QA Engineer (India) — Join SynthioLabs (YC X25).SynthioLabs growing fast and looking for a.Design and maintain detailed test plans and test cases. Run daily testing cycles across web and mobile apps...Show moreLast updated: 11 days ago

Promoted
New!

Site Quality Head [Only 24h Left]

Knovea Pharmaceutical Private LimitedIndia

Designation : General Manager / Sr.Experience required : 20 years to 25 years.Responsible for management of all aspects of Quality functions including Quality Assurance (QA), Quality Control (QC) and...Show moreLast updated: less than 1 hour ago

Promoted
New!

(Apply in 3 Minutes) Regulatory Compliance Specialist -2+

Jupiter AI LabsIndia

We are seeking a Regulatory & Compliance Specialist on a contract basis to support our compliance requirements in India and international destination countries. This role is ideal for professionals ...Show moreLast updated: less than 1 hour ago

Promoted

Manager – Sterile Micro / EM Compliance

Immacule LifesciencesIndia

Promoted
New!

Only 24h Left : Quality Head( Cable industry)

SamridhiIndia

Quality Management System (QMS) : • Develop, implement, and maintain the Quality Management System (QMS) in line with ISO and other relevant standards. Conduct regular audits to ensure compliance wit...Show moreLast updated: less than 1 hour ago

Promoted

▷ (Apply in 3 Minutes) Plant Head - Medical Device

MEDIPLUS® | Shree Umiya Surgical Pvt. Ltd.India

The Plant Head will be responsible for overall management, planning, and control of plant operations — ensuring optimum utilization of manpower, materials, and machinery while maintaining the highe...Show moreLast updated: 6 days ago