Quality Control Manager (m/f/d)

Your Profile:

• With Bachelor's/Master's in pharmacy or master's degree in science (With analytical chemistry background)
  
• Experience in pharmaceutical products and processes
  
• Strong leadership/team management skills and experience.
  
• Credible and confident communicator (written and verbal) at all levels.
  
• Strategic thinker with the ability to influence.
  
• Demonstrate high level of ethics and integrity.
  
• Strong analytical and problem-solving ability.
  
• Working knowledge of Microsoft excel, word, power point etc.
  
• Relevant experience in the regulated pharmaceutical industry.
  
• Experience with health authority inspections and third-party audits
  
• Technical writing skills

Your Tasks:

• Ensuring the development of departmental SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being 'fit for purpose' operationally and commercially.
  
• Responsible for ensuring thorough review of analytical data and ensuring reviews are performed within the required timeframes to meet business milestones. Ensure any issues are escalated as appropriate through the relevant tier processes.
  
• Ensure local work procedures are continuously improved and any efficiency gains are captured through procedural improvements.
  
• Conduct risk assessment for analytical activities and enforce improvements through procedural implementations or improvements.
  
• Approval of instrument qualification documents in line with regulatory requirements
  
• Responsible for review and approval of protocols and reports such as but not limited to method validation, method transfer, process validation, cleaning analytical method validation and stability study.
  
• Timely reporting of any risks to compliance or product quality to quality head.
  
• Approval of all change controls, deviations, CAPA that arise from quality control laboratory with cross functional team identified.
  
• Ensure completion of method transfer and method validation/verification before routine testing.
  
• Ensure preparation and availability of calibration schedule for QC equipment and ensuring its compliance.
  
• Managing all validation activities, including validation strategy and approval of protocols and reports.
  
• Ensuring appropriate investigation of discrepancies, errors, OOS, OOT and action. Ensuring that the Quality Control department meets or improves on budget, cost, volume and efficiency targets (KPIs) in line with business objectives.
  
• Identify resource and skill gaps and recruit staff as required and effectively outsource projects as needed.
  
• Lead an experienced team of professionals and provides training on quality policies and procedures, and regulations and guidelines, both existing and emerging
  
• To implement and ensure current GMP, safety and GLP norms in the laboratory testing areas, respectively.
  
• Awareness on current guidelines, policies, procedures, and techniques of quality control.
  
• Upkeep of laboratory with respect to compliance and safety.
  
• Ensure appropriate work allocation to the team members in QC and ensure optimum utilization of resources.
  
• To review and approve specifications, standard operating procedures, trends, Technical Reports, out of specifications and Deviation Reports as per requirement.
  
• To review and approve Packing materials, Raw materials, Intermediate products, finished products, stability samples and other miscellaneous samples.
  
• Review and approval of documents of QC.
  
• Responsible for ensuring appropriate training to all the subordinates and enhancement of analytical skills and competency.
  
• Providing usage decision of RM, PM, FP tested samples.
  
• Perform due diligence and evaluation of new product introductions.
  
• Knowledge of Process Excellence tools (Lean, Six Sigma), with a proven track record of deploying these tools to improve operational
• performance.
  
• Any other work assigned by Quality Head.

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