About the Company
The firm is specialized in the products like pharmaceuticals, Beauty product industry and also equipped with Hospitality, skill development. The firm located at New Delhi. The Company established in the year 1991 with many core values of discipline in operations, Vision without action is a dream. Plan work and attitude over aptitude.
About the Job
Position: SME-Quality Control (Manager/Dy. Manager)
#hiring #quality Department: Corporate Quality (CQA)
Location: Gurugram
Experience: 10-12 Years
Qualifications: M.Sc. (Chemistry) / B. Pharm / M. Pharm / Ph.D.
Reporting To: Vice President – Corporate Quality
Job Responsibilities:
1. Close Monitoring of Quality Control department activities at various sites of the company.
2. Periodical verification of audit trails, quality control systems and stability activities.
3. Review and ensuring the Quality management system activities like Deviations, change controls, Incidents, Investigations, CAPA, Complaints and Route cause analysis, OOS/ OOT based on requirement.
4. Quality Risk management for the quality control equipment/instruments and computer systems.
5. Qualifications of analytical labs:
Ø Execution of the audits
Ø Follow up with analytical labs for audit compliance
Ø Certification
Ø Preparation and maintenance of technical agreements
Ø Periodic qualification as per schedule
6. Regulatory guidelines, Pharmacopeial updates review and follow-up for implementation.
7. To provide training on, good quality Control practices, Good Chromatographic Practices, Good documentation practices and Data reliability/Integrity for continual improvement.
8. Ensuring the technical review of Stability management, Specifications, STPs, General Procedures based on requirement.
9. Conduct quality internal audits, compliance audits/ vendor audits.
10. Scheduling of self-inspections and coordination to conduct as per the schedule.
11. Identification and implementation of the necessary quality improvements based on customer interaction or audit compliance.
12. To support for the readiness of audits and follow-up of their compliance.
Experience of working with instruments like HPLC, UPLC, ICPMS, LC-MS/MS, GC-MS/MS, Auto titrator, Ion Chromatography.
If you are willing to relocate to Gurugram, please apply in full confidence and send your resume by writing position applied for in the subject line to [email protected]
GLP Lead ( QC)
Position: GLP Lead – Quality Control (Manager / Dy. Manager)
Department: Centralized Analytical Laboratory
Location: Gurugram
Experience: 10-12 Years
Qualifications: M.Sc. (Chemistry) / B. Pharm / M. Pharm / Ph.D.
Reporting To: Vice President – Corporate Quality
Job Responsibilities:
1. Ensure Development, Implementation & Maintenance of Management System in line with IS/ISO/IEC 17025:2017, ISO 9001:2015, Schedule L1 of Drug & Cosmetic Act 1940 in the laboratory.
2. Implement and monitor quality systems/policies in the laboratory.
3. Ensure and monitor the compliance in the laboratory with respect to SOP’s and applicable regulatory guidelines.
4. Participate in the meetings for technology transfer with regulatory and plant as planned by project management.
5. Evaluate the contract testing and contract manufacturing sites with user department.
6. Participate in the internal/external inspections and keep track of compliance activities.
7. Approve qualification activities related to qualification of facility, software, instrument and/or equipment.
8. Review/approve Standard Operating Procedures, Investigation protocols/reports, Standard Test Procedure & Specification.
9. Review/approve quality management system documents e.g. Change Control, deviation, LIR, OOS, OOT, OOE, Market Complaints, CAPA etc.
10. Review/approve protocols and reports e.g. Analytical Method Development (AMD), Analytical Method Validation (AMV), Analytical Method Transfer (AMT), Product Development Report (PDR), Stability Studies etc.
11. Control and monitor the document issuance/archival.
12. Verification of audit trails.
13. Review and approve analytical raw data for COA preparation.
14. Review and approve COA and share it with the client.
15. Experience of working with instruments like HPLC, UPLC, ICPMS, LC-MS/MS, GC-MS/MS, Auto titrator, Ion Chromatography.
If you are willing to relocate to Gurugram, please apply in full confidence and send your resume by writing position applied for in the subject line to [email protected]