Hetero Drugs Ltd. Job Opening for GENERAL MANAGER QUALITY CONTROL
Department: Quality Control
Experience: 20 to 25 years
Location: Nakkapalli
Qualification: M.Sc Chemistry
Job Description
General Manager QC:
General Manager - Quality Control responsible to oversee the operations of Quality Control functions of Active Pharmaceutical Ingredients(API).
Managing all administrative and technical issues of Quality control
Review of analytical results.
Ensuring the preventive maintenance and calibration reports as per the schedule
Ensuring Good laboratory practices and Laboratory safety standards
Responsible for Review of analytical data (worksheet and backup data) received from various sections of QC laboratory
Responsible for overall monitoring of Quality Control system
Must have exposure of stability management and analytical method validation along with routine commercial and exhibit batch analysis.
Responsible for leading operations of QC and ensuring the quality control processes, Review and analysing the results, and offer expertise views.
Verify all processes are complying to established specifications, protocols and established quality standards.
Ability to represent and lead Audits as front runner
Draft, Review, revise and verification of quality standards and Analytical reports and instruct to record and report quality data.
Investigate and handle customer complaints of QC and perform root cause anlysis
Ensure the team audit readiness and periodical review of performance of quality control systems to ensure efficiency.
Ensuring the regulatory compliance of QC as applicable with Comprehensive knowledge of quality control systems, procedures, protocols, standards and regulatory requirements.
Should have experience in handling of Regulatory Inspections and the queries and handling of Audits & Regulatory compliance
Thorough knowledge of method transfer, method development, technology transfer documents, Qualification and validations
Corrective and Preventive actions to address the probabilities of re-occurrences and to fix them
Expert in analytical Investigations
leading QC team of 200 members , People management skills
Developing procedures
Periodical review of expenses and budgetary controls
Handling of Non-conforming results I.e OOS/OOT - Quality Control - handling out of specification/Out of trends investigations Adhering to the respective standard operating procedures/protocols.
Review QMS documents e.g. Change control/Deviation/Incidents-Discrepancy if any
To perform periodic and audit trail review of computerized systems in laboratory
To support the initiatives undertaken by corporate quality for further strengthening of process, leading change management processes
Approve SOPs, Guidelines/Policies as applicable.
Guide and mentor QC teams
To assess the existing facility and inventories v/s future requirement and offer proposals subsequently
Good communication skills and people management with decision making skills, Sound knowledge on QC operations and compliance and thorough knowledge of CSV process (Preferred Candidate from USFDA approved pharmaceutical API facility )
20 + years of Experience, At least 15 years experience in Managerial role (Must have the experience in leading of Quality Control in regulatory approved facility only)
Email ID talent@heterodrugs.com
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