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.
- 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).
|Other Benefits||As per company policy|
|Apply Instruction||Send your CV to firstname.lastname@example.org
Applicant must enclose his/her Photograph with CV.
|Address||Genvio Pharma Ltd.House 7
Road 2/d; Block J; Baridhara, Dhaka 1212
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