Job Description

Division
Quality
Department
Quality
Employment Type
Permanent
Job Purpose
Drive the implementation of quality control systems through all QC sections (Routine, Non Routine, Product Registration Cell & Stability) at a unit to ensure testing is done as per GLP and meeting established standards and regulatory requirements
Accountabilities
I. Develop the quality development strategy for a unit and monitor its implementation to ensure it meets the business requirements and customer deliverables
II. Plan and monitor the quality control activities in the laboratory by reviewing status of batch release and related lab activities to meet the regulatory requirements w.r.t. lead time, quality, service, OTIF and cost
III. Provide guidance for continuous improvement initiatives by identifying areas for optimisation of resources to reduce cost and facilitate smooth operations
IV. Identify critical and high-risk non-conformance / issues from review of audit reports and SOPs; trigger CAPAs where required in order to ensure effective handling deviations, recall and complaints
V. Monitor the implementation of all laboratory activities as per SOPs to ensure compliance to cGMP, GLP and regulatory requirements
VI. Drive people development within the quality control function at a unit in order to maximize performance and achieve better control of operations
Education Qualification
B. Sc. / M.Sc. (Chemistry) or B. Pharm
Relevant Work Experience
12 years of experience in quality control of a pharmaceutical organisation
Competencies/Skills
Collaborate to Succeed
Innovate to Excel
Perform with Accountability
Lead with Empathy
Act with Agility
Strong Domain Knowledge
People Management
Job Location
Rangpo
Shift Hours