Sr. Specialist - QA (Sterile)

Position Summary :

• In this role you will be responsible to adhere and ensure compliance cGMP principles and maintain them in effective manner.

• Deviations investigation

• Participate in the media fills.

• Preparation of Process /Facility/Equipment Risk assessments

• Should have Quality mindset in the process and procedural review.

• Regulatory Audit exposure and Participate in Internal and External Audit programs.

• Perform in-process quality check activities according to SOP in production / packaging departments (Sterile Injectable) in complying with cGMP principles and captures test results in batch records.

• Check the required tests for all products during production / packaging process.

• Inspect and check incoming materials by confirming specifications and return unacceptable materials.

• Revise all documents for in process control and perform a quality review of logbooks.

• Responsible to revise and document for inspection results and complete all required documents for in process control by completing reports and logs, summarizes re-work and waste, and inputs data into quality database on SAP system.

• Preparation of Annual Product Quality Review reports.

• Ensure the in-process check equipment's are adequately calibrated and functions properly.

• Perform and check the line before start (production/packaging) and give the clearance for the work.

• Check all material required for manufacturing steps (production/packaging).

• Maintain accurate records and perform tests on all activities conducted in the plant.

• Plan and assign daily job duties to fulfil the plan.

• Accomplish quality and organization goals by completing related results as needed.

• Maintain safe and healthy work environment by following standards and procedures and complying with regulations.

Core Competency :

• In terms of competency, you are highly result-oriented with keen sense of accountability & ownership.

• High on compliance adherence, having strong diligence, initiative-taking and flexible.

• Effective communication, interpersonal, and collaboration skills.

• Should be having good learners mind to understand and grasp new learnings.

• Motivated, organized, focused & overall compliance.

• Must be able to manage tasks, plan workload effectively, priorities and easily adapt to changing situations.

• Ability to understand new learnings and implant in workplace.

Qualifications, Key Experiences / Functional Knowledge Requirements:

• Bachelor I master's degree in pharmacy

• Knowledge on EU Annex-1

• Minimum 3 years in quality operation in Sterile manufacturing

• Good Computer knowledge and knowledge of QMS system “Agile, Track wise, Ampelogic”

• Proficient in English.

• Quality and Business decisions taker

• Good Knowledge and command on cGMP

• Risk Assessment knowledge