Glenmark Pharmaceuticals | General Manager Quality | himachal pradesh

2 weeks ago

himachal pradesh, India Glenmark Pharmaceuticals Full time
Responsibilities :
To monitor and ensure implementation of Quality Systems at Baddi manufacturing site of Glenmark Pharmaceuticals Ltd. and provide input for continuous improvement and enhancement of current Good Manufacturing Practices (cGMP) compliance and product quality.
To prepare and lead regulatory and customer audits and ensure compliance within given time line for corrective and preventive actions (CAPA).
Co-ordinate with functional departments for investigations. Ensure timely.
Implementation of corrective and preventive action (CAPA) plans as committed.
To lead and provide necessary inputs to Quality Assurance (QA), Quality Control (QC) team at Baddi sites and for continuous up-gradation.
To co-ordinate with corporate purchase department and ensure that the non-conformance reports (NCRs) are addressed and improvement at Vendor’s end are implemented.
To co-ordinate with Production, research and development (R&D) and regulatory affairs (RA) functions and support on quality related matters.
To co-ordinate with Corporate Quality Assurance (CQA), R & D and Regulatory Affairs department for products manufactured and support for various submissions and new products planned.
To ensure planning for new products introduction at manufacturing sites and satisfactory Technology Transfer in co-ordination with R &D, Glenmark Pharmaceuticals Limited (GPL).
To co-ordinate with CQA for implementation of policy and guidelines and other issues related to stability and quality.
To monitor budget expenditures and control the same, suggest cost reduction programs.
To oversee that quality systems, procedures, validation master plan, site master file are maintained and in current state and implemented effectively.
To monitor product, methods and procedures for continuous improvement.
To strive for sustainable compliance at Baddi manufacturing site.
To monitor and ensure implementation of training planner and audit calendar at Baddi manufacturing site. Verify the training periodically.
Evaluation of Market Complaints and to ensure the implementation of corrective and preventive actions (CAPA) if any.
To monitor and ensure the shop floor compliance in accordance with the SOPs and regulatory requirements.
To develop SMEs for unit operation and ensure All Time Readiness at site.
Authorization and approval of SAP activities.
Review and Approval of Standard Operating Procedures, process validation, cleaning validation, Hold time protocol reports, PQR and Site master file.
Authorization of monthly QMS report.
Monitoring internal audits & its compliance and certification of internal auditors.
Authorization and approval of service contracts and technical agreements.
Provide the site information on critical quality indicators periodically to top management.
To ensure adequate resources are available at site to maintain All Time Readiness at site.
To perform Batch Release /Rejection activity.
Educational Qualifications
B.Pharma/M.Pharma/M.Sc
Experience
Representation in Audits, Validation & Qualification, QMS implementation, SOP Harmonization, Process improvement.
Knowledge and Skills ( Functional / Technical )
cGMP Guidelines
21CFR
Quality Management System
Behavioural Attributes
Leadership
Team-Building
Coordination

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