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Published on: 22 Sep, 2020

Application Deadline: October 05, 2020

Vacancy: N/A

Head of Quality Compliance

Description

• Assurance and enforcement of cGMP in production, quality control, warehouse, engineering facilities. On time Management of compliance activities like risk management, CAPA management, deviation, change control, market complaint, returned goods management, self Inspection, internal & external audit etc
• Preparation & implementation of SOP’s, Protocol, SMF, VMP, DMF, CTD & eCTD, Quality Manual, APQR, QMS related documents and other quality documents.
• Ensuring calibration, process validation, analytical method validation, cleaning validation, vendor validation and qualification of machinery, equipments, HVAC systems, compressed air system, purified water system, steam system and effluent treatment system.
• Preparation of training module and conduct GMP training and others training for the relevant factory personnel.
• Preparation and update of specifications of raw materials, packaging materials and finished products.
• Ensuring physical, chemical & biological tests of raw materials, intermediates, bulk and finished products of all dosage forms, dispensing of raw materials, release & rejection of raw materials, packaging materials and finished products.
• To evaluate proper batch documentation system, reviewing data, assessing & solving the problems.
• Identification of the part of the process where in process control check are required and its implementation.
• Monitoring and control of the manufacturing environment and plant hygiene.
• Responsible for release the batch of product for marketing.
• Fulfillment of regulatory requirements of home and abroad.
• Assist the Executive Director (Plant) to develop quality standards, rules & regulations and accomplish the goals and strategic plans.
• Coordination with Quality assurance, Quality Control, Product Development, R&D, Production and Engineering Department for proper support in all quality related matter/activities.
• Conducting any type of inspection by ISO and others Regulatory bodies from home & abroad. Completing the inspection report according to inspected results.

Experience Requirements:

• At least 20 year(s).
• The applicants should have experience in the following area(s): cGMP, Formulation, Pharmaceuticals, Quality Controller/ Assurance, Quality Management, Regulatory Affairs.
• The applicants should have experience in the following business area(s): Pharmaceuticals.

Additional Requirements:

• Age 45 to 50 years.
• Must have working knowledge on Product development and R&D section.
• Must have Administrative, Leadership & Managerial skills.
• Must have Strong analytical, strategic thinking, commendable presentation, decision making and problem-solving skills with the ability to work independently under the strictest deadline are required.
• Must have excellent communication in English (Written & Verbal) and Interpersonal skills.
• Must have Efficiency, flexible, high level of professionalism and ability to work under pressure.
• Must have Positive work ethics and result oriented for assigned responsibilities.
• Should be self-driven and hardworking.
• Must have sound knowledge in computer applications.
• Candidate must have to stay with family at Pakundia or Kishoreganj.

Job Location : Plant at Pakundia, Kishoriganj

Experience Requirements:

Salary: Negotiable

Compensation & Other Benefits:

• Mobile bill, Tour allowance, Provident fund, Insurance, Gratuity, Benevolent Fund.
• Lunch Facilities: Company Provided in-office time.
• Salary Review: Yearly.
• Festival Bonus: 2 (Yearly).
• Foreign Tour.

Jobs Source: online

Apply Instruction

Company Information

Delta Pharma Limited

Note:

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