Executive, Quality Assurance

Job Description / Responsibility

• Monitoring dispensing of raw materials as well as manufacturing & packaging processes in compliance with GMP.
• Monitoring IPQA, BMR-BPR checking, change control, deviation control activities, CAPA and batch release activities.
• Generating all the required documents for Production operation i.e. Formulation Order (FO), Batch Manufacturing Record (BMR), Batch Packing Record (BPR) and SOPs.
• Compilation of Batch History i.e. BIF, FO, BMR, PO, BPR etc. & handling of Retention Sample and ensure proper investigation of quality incidents.
• Compilation and controlling the Deviation, Change Control and Incidents reports.
• Reviewing Analytical Data of commercial batches for QA approval.
• Preparation and control of SOPs and ensure QMS related documentation.
• Monitoring & execution of process validation, cleaning validation, performance qualification of process machineries.
• Preparation, review and implementing batch sampling plan.
• Monitoring & execution hold time study and equipment qualification.
• Preparation of APQR (Annual Product Quality Review).
• Review of Artwork/Printing Specification for top foil, bottom foil, Strip, insert, inner cartoon, shippers etc. for QA approval.
• Review and Compilation of Data required for Regulatory submission.
• Preparation and compilation of Dossier and other regulatory documents.
• Performing vendor selection and qualification/ new vendor selection.
• Performing the self-inspection and submit report on findings to receptive authority and to take part in to the follow up action.
• Regular inspection of the plant, to ensure that good house-keeping and approved procedures are being practiced to ensure that at all times it meets the standards of cGMP.
• Any other work assigned by Head-QA and COO.

Basic Qualifications

• M. Pharm from any reputed University.
• Age 25 to 30 year(s)
• 5-6 years of experience in the pharmaceutical industry
• Detail-oriented, ability to work independently
• Ability to visualize and diagrammatically explain processes
• Strong interpersonal and communication skills, both written and verbal
• Strong computer proficiency
• Strong MS Word, MS Excel, MS Visio, Adobe Acrobat background
• Familiar with root cause analysis and Corrective Action / Preventive Action procedures
• Communication- Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Response well to questions; Writes clearly and informatively; Presents numerical data effectively
• Leadership- Exhibits confidence in self and others; Inspires and motivates others to perform well; Accountable for behaviours and their impact on others; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others
• Strategic Thinking – Develops strategies to achieve organizational goals; Understands organization’s strengths & weaknesses; Adapts strategy to changing conditions. Critically evaluates quality systems to propose best practices.
• Computer skills: MS Office (Word, Excel, PowerPoint and Access).