Sr. Executive, Quality Assurance

Job Description / Responsibility

• Design, development, implementation, monitoring and controlling overall documentation system as per the GMP requirements and ensure QMS related documentation.
• Preparation, review, control, implementation, distribution, retrieval or destruction of all GMP related SOPs, SMF, QMS, VMP, CV, CVP, Quality Manual, Master Procedure, Facility Commissioning, Root Cause Analysis etc.
• Coordination and ensuring required initial and continuous training of Manufacturing/plant personnel is carried out and adapting according to the need.
• Preparation of Training Manual, Curriculum, Schedule and conduct training (GMP, GDP, SOP, Master Documents etc.) and maintaining training records of all the employees.
• Monitoring operation and daily maintenance activity of Stability Chambers (Photo Stability, Humidity Chamber and 2 Walk In Humidity Chambers) and Stability Room.
• Preparation & execution of Stability Protocol, Charging/Discharging Schedule and handling of Stability Samples as per ICH Guideline.
• Issue all required documents for Manufacturing i.e. Batch Initiation Form, Sampling Advice Form, FO, PO, BMR, BPR, Line Clearance Documents etc.
• Assigning Batch Number, MFG, EXP Date, BMR, BPR, FO, PO and TT Number etc.
• Preparation, review and implementing batch sampling plan.
• Monitoring dispensing of raw & packaging materials as well as manufacturing & packaging processes in compliance with GMP.
• Monitoring IPQA, BMR/BPR filling, change control and batch release activities.
• Handling Batch document, Retention Samples as well as Retention Room.
• Handling Market Compliant, Deviation, QIR, CAPA, NCR & Rejections and ensure proper investigation of quality incidents.
• Compilation and controlling the Deviation, Change Control and Incidents reports.
• Organizing and performing the self-inspection and also to and submit report on findings to receptive authority and to take part in to the follow up action.
• Preparation & Review of APQR (Annual Product Quality Review)
• Documenting & giving technical support (where needed) to all the validation activities including process validation, cleaning validation and the qualification (i.e. DQ, IQ, OQ and PQ protocol and report) of all the process equipment.
• Review and Compilation of Data required for Regulatory submission i.e. Dossier, Recipe, DTL sample etc.
• Review of Artwork/Printing Specification for top foil, bottom foil, Strip, insert, inner cartoon, shippers etc. for QA approval.
• Handling of Auditors from various regulatory agencies, Genvio affiliates, Third party affiliates & Visitors in GMP area.
• 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.
• Where necessary to make recommendations to improve the overall efficiency and appearance of the plant to ensure that it meets the 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).