14 Nov
|
Orbitouch Outsourcing Private
|
Ankleshwar
14 Nov
Orbitouch Outsourcing Private
Ankleshwar
POSITION: Quality Control Head
Location-Ankleshwar
Experience-15 years
Ctc range-upto 16 lpa (depends on interview)
Working Days - 6 days
Key Roles & Responsibilities
- Manage and supervise all QC laboratory activities, ensuring effective implementation of quality systems and compliance with GMP/GLP requirements.
- Ensure timely testing, review and approval of raw materials, packing materials, in-process samples, finished products and water samples.
- Review and approve analytical reports, Certificates of Analysis (COA), specifications, STPs and other QC-related documents.
- Ensure proper investigation, documentation and closure of OOS, OOT, deviations, incidents and quality complaints.
- Ensure proper calibration, validation, maintenance and qualification of laboratory equipment and instruments.
- Monitor stability studies, retained samples and ensure adequate stability data to support product shelf life and storage conditions.
- Manage QC laboratory manpower, training, analyst qualification, performance and resource requirements.
- Ensure proper management of chemicals, reagents, reference standards, volumetric solutions and laboratory inventory.
- Ensure data integrity, audit trails, access controls and security of computerized laboratory systems.
- Coordinate with QA, Production and other departments for quality-related activities, product release and change control.
- Ensure laboratory housekeeping,
safety practices and proper disposal of chemical waste and analyzed samples.
- Participate in internal audits, regulatory inspections, validation activities and implementation of corrective and preventive actions.
- Review and update QC-related SOPs, procedures and pharmacopoeial requirements in line with current regulatory guidelines.
- Ensure timely communication of critical quality issues, regulatory observations and product defects to management.
- Ensure compliance with applicable environmental management requirements, statutory regulations and company policies.
Authority
- Approve or reject materials and products based on compliance with approved specifications and quality requirements.
- Review and approve QC-related documents and analytical results.
- Initiate investigations and recommend corrective and preventive actions.
- Ensure independent functioning of the QC department in coordination with QA.
Application Question(s):
- Are you qualified with Diploma/Degree in Science or relevant field?
- are you most comfortable with location Ankleshwar?
- what is your current annual salary / ctc?
- what is your expected annual salary / ctc?
- How many years of Proven experience in Quality Control in api pharma?
- what is your notice period? (in days)
- How would you rate yourself on a scale of 1 to 10?" between your experience /skills & as required experience in job descriptions?
Work Location: In person
📌 Quality Control Head (Ankleshwar)
🏢 Orbitouch Outsourcing Private
📍 Ankleshwar