QA - Officer to Manager

3 weeks ago

Halol, India Job Excel Full time

Responsibilities:

  1. QA Officer:

    • Execute quality assurance activities as per standard operating procedures (SOPs) and regulatory requirements.
    • Conduct routine inspections and audits of manufacturing processes, facilities, and documentation.
    • Assist in the investigation of deviations, non-conformances, and customer complaints.
    • Support in the implementation of corrective and preventive actions (CAPAs) to address quality issues.
    • Participate in the preparation and review of batch documentation and quality records.

  2. Senior Executive:

    • Oversee and coordinate QA activities across multiple departments or product lines.
    • Provide guidance and support to QA Officers in executing quality assurance tasks.
    • Review and approve batch documentation, change controls, and validation protocols.
    • Lead investigations into complex quality incidents and ensure timely resolution.
    • Contribute to the development and revision of quality policies, procedures, and guidelines.

  3. Assistant Manager:

    • Manage a team of QA professionals and allocate resources effectively to meet objectives.
    • Develop and implement quality improvement initiatives to enhance processes and systems.
    • Act as a subject matter expert in regulatory requirements and industry best practices.
    • Represent the QA department in internal and external audits, regulatory inspections, and client meetings.
    • Monitor key performance indicators (KPIs) to assess the effectiveness of quality systems.

  4. Deputy Manager:

    • Provide strategic direction and leadership in all aspects of quality assurance activities.
    • Drive continuous improvement initiatives to optimize quality management processes.
    • Collaborate with cross-functional teams to resolve complex quality issues and implement preventive measures.
    • Mentor and coach junior team members to foster their professional development.
    • Contribute to the development and execution of the company's quality strategy and objectives.

  5. Manager:

    • Oversee the overall quality management system and ensure compliance with regulatory standards.
    • Develop and maintain strong relationships with regulatory authorities and industry stakeholders.
    • Lead the preparation and execution of regulatory submissions and inspections.
    • Drive a culture of quality excellence throughout the organization through training and awareness programs.
    • Provide strategic insights and recommendations to senior management on quality-related matters.

Requirements

Qualifications:

  • Bachelor's or Master's degree in Pharmacy. Additional qualifications in Quality Assurance or Regulatory Affairs are preferred.
  •  Years of relevant experience in the pharmaceutical industry, with increasing levels of responsibility for higher positions.
  • Sound knowledge of cGMP (current Good Manufacturing Practice) guidelines and regulatory requirements (e.g., USFDA, ROW, EU, CDT, EMA, ICH).
  • Strong analytical skills and attention to detail, with the ability to identify and resolve quality issues effectively.
  • Excellent communication, interpersonal, and leadership skills, with the ability to collaborate across functional teams.
  • Certification in Quality Management Systems (e.g., ISO 9001) and auditing techniques is desirable for managerial roles.


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