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).
Job Nature Full-time
Job Location Mymensingh
Salary Range Negotiable
Other Benefits As per company policy
Apply Instruction Send your CV to jobs@genvio.com.bd

Applicant must enclose his/her Photograph with CV.

Address Genvio Pharma Ltd.House 7

Road 2/d; Block J; Baridhara, Dhaka 1212

Deadline September 30,2019
No. of Vacancies