Manager, Quality Assurance

Job Description

Title: Manager, Quality Assurance

Company Name: UniMed & UniHealth

Vacancy: --

Age: At most 40 years

Job Location: Gazipur

Salary: --

Experience:

• At least 10 years

• M.Pharm having Pharmacy Council registration

• At least 10 years

• Age At most 40 years

• Having good communication skill both in English and Bangla

• Good computer knowledge

• At least 10 years experience in reputed pharmaceutical company (s) out of which 2-3 years in similar position will be preferred

• Implement all quality functions of the Pharmaceutical Manufacturing Plant

• Prepare and revise quality documents, this includes Site Master File, Quality Policy, Quality manual, Validation Policy & Documents, Validation Master Plan, Calibration master plan, Training manual, SOPs etc.

• Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulatory guidelines, company procedures and policies

• To monitor calibration process of monitoring and measuring equipment, calibration schedule and relevant documentation.

• Coordination and execution BMR and BPR approval & issue of BMR and BPR for production

• Coordinate and execute all the validation, qualification and technology transfer activities

• To check and monitor that DQ, IQ, OQ & PQ of facilities, equipment and utilities are performed and documented as per regulatory requirements

• To implement and maintain of ISO 9001 : 2015 QMS

• Acts as a quality liaison with regulatory authorities, ISO 9001 : 2015 QMS inspectors, and external auditors during inspections

• Oversee the nonconforming product, market complaint, product recall, change control, deviation procedure, release, rejection, annual product quality review (APQR) vendor qualification and corrective and preventive actions.

• Co-ordination with other department to enhance and implement company`s Quality Management System.

• We offer: Excellent work environment, attractive compensation package, medical assistance for employee and family members, provident fund, gratuity, festival bonus, profit share, group life insurance, faster career progression, requisite training