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.
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).
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