QA Sterile Manager

1 week ago

Dewas India SUN PHARMA Full time

Job Description

Job Description

Position: QA Sterile Manager

Department: Quality Assurance

Designation: Manager - I

Education Qualification: M.Sc. in Biotechnology / Microbiology / Chemistry

Total years of Experience: 10+ Years

Job Role: Management of Quality Assurance functions of Manufacturing Block P.

Responsibilities

- Ensure that manufacturing and packing of the batch is executed and records are completed and reviewed in accordance with established SOPs and cGMP regulations.
- Conduct certification of batch production records for compliance and stage-wise completion.
- To release / reject the Batch after complete review of batch and related quality documentation.
- Tracking and monitoring of QMS system.
- Ensure logical closure of deviations and investigations of related product before release.
- Conduct thorough investigations along with production for any complaints / deviations/ OOS / stability failure for products manufactured at the site and logical / timely closure of Complaints.
- To ensure contamination controls implemented and followed at site as per contamination controls strategy (CCS) and respective procedures.
- Work directly with planning, QC, other QA functions, and Regulatory Affairs to ensure Batches are released to meet supply chain requirements.
- Participate in self-audits of facility and equipment in partnership with Manufacturing and Engineering to ensure readiness for operations.
- Participate in Aseptic simulation (Media Fill) activity, Monitoring and Implementation for PENEM DF.
- Identify continuous improvement opportunities to improve compliance, process clarity, and operational efficiency.
- Review and approve master batch production records (Manufacturing / packing) and SOPs.
- Review and approve equipment qualification & process validation protocols and reports for accuracy, completeness, and traceability as well as adherence to protocol / procedures.
- Review and approve Annual Product Review (APR) reports for the products as per the schedule.
- Stability sample management of finished goods.
- Management of control sample pertaining to collection, review, storage and destruction.
- Management of line clearance, in-process check, coding approval and water sampling.
- Review and approval of IPQA instrument calibration record.
- Management of IPQA activities for Block-Penem.
- Review and approve artwork of Packaging material, STP and Specification.
- Provides appropriate training and development to support staff to meet their respective job responsibilities.
- Work in partnership with Manufacturing, Engineering, and QC to increase knowledge and understanding of cGMPs and improve practices and procedures.
- Review activities related to the Microbiology Laboratory.
- Review activities related to the beta-lactam containment monitoring.
- Compliance with Quality Policy of the organization.
- Improvement of System and procedures, Quality of products manufactured and delivered.

  • Manager - Production-Sterile

    1 week ago

    Dewas, India SUN PHARMA Full time

    Job Description Job Title Manager - 1 (Production-Sterile) Business Unit Sun Global Operations Job Grade G10 Location : Dewas SGO At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your...

  • Manager - Production-sterile

    2 weeks ago

    Dewas, Madhya Pradesh, India Sun Pharmaceutical Industries Full time

    Job Title Manager - 1 Production-Sterile Business Unit Sun Global Operations Job Grade G10 Location Dewas SGO At Sun Pharma we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step take charge of your journey and thrive in a supportive community Are You Ready to Create Your Own Sunshine ...

  • Manager- Sterility Assurance

    3 days ago

    Baddi, Himachal Pradesh, India, Himachal Pradesh Panacea Biotec Full time

    Job Responsibilities:Oversight of compliance with respect to Sterility Assurance to ensure alignment to the Site, Global and Regulatory requirements, including but not limited to: Aseptic Practices, Environmental Monitoring, Cleaning & Sanitization, Sterilization, Media Simulation, Change Over Controls, Clean Utilities, Gowning & Personnel Flow.Assure...

  • Senior Manager

    3 days ago

    Dewas, India SUN PHARMA Full time

    Job Description Job Description Position: Engineering Penem Head Department: Engineering and Projects Designation: Senior Manager II Total Years of Experience: 15+ Years Education Qualification: B.E. in Electronics Job Role: Accountable for Engineering and Maintenance related activities for Block P (Sterile), Block F (OSD), Supporting Facilities...

  • Associate Manager Quality Assurance

    5 days ago

    Chennai, India Pfizer Full time

    Job Description Role Summary - Responsible for reviewing documents related to product development, analytical data (including electronic data, chromatographic data, and audit trails), as well as instrument and equipment qualification - Accountable for ensuring data integrity compliance and adherence to SOPs during the review of both hard copy and...

  • QA Manager

    2 weeks ago

    Bengaluru, India Igniting Minds Aerospace Private Limited Full time

    Job Description Company Description Igniting Minds Aerospace Private Limited, an AS9100 Rev D Certified Company, specializes in the manufacturing of Aerospace Components, Aerospace Tooling, and Ground Support and Handling Equipment. Our advanced technology and experienced team enable us to produce high-quality precision products and deliver them to clients...

  • Qa Manager

    3 weeks ago

    India CIEL HR Full time

    Hi Greetings of the Day We have a critical opening with our client QA Manager for Bangalore Mumbai Pune Chennai Coimbatore Gurgaon location Experience 10 yrs Location Bangalore Mumbai Pune Chennai Coimbatore Gurgaon Mode of Employment Fulltime Job description Must Have Skills Ability to understand Requirements and translate them into test...

  • ▷ Urgent Search! Sterile Manufacturing

    2 weeks ago

    Bengaluru, India Syngene International Limited Full time

    Job Description Date: 15 Sept 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Development Services Job Title: Sterile Manufacturing, Filling Supervisor Department: Formulation production Job Location: Bengaluru, India About Syngene: Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing...

  • ▷ Immediate Start: DGM

    3 days ago

    Kharagpur, India SUN PHARMA Full time

    Job Description Job Title DGM Operations (Sterile) Business Unit Sun Global Operations Job Grade G8 - DGM Location : Halol Key Responsibilities At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create...

  • Qa specialist

    2 weeks ago

    India K3-Innovations, Inc. Full time

    Commitment: Full-Time Contract (30–40 hours per week) Location: Based in India, Remote – Eastern Time Zone (preferred) or Mountain Time Zone Reports To: Clinical QA Lead / Director of Quality Position Overview We are seeking an experienced QA Specialist / Manager-level contractor to provide day-to-day clinical quality assurance (QA) support...