B.Pharma QC Specialist Post Vacancy @ Intas – Apply Now

B.Pharma QC Specialist Post Vacancy @ Intas – Apply Now

B.Pharma QC Specialist Post. Intas Pharmaceutical Limited invites undergraduates Pharma candidates for Quality Control Specialist post vacancy. Candidates with experience in Pharma filed may apply for this job post via online mode. Check out all the details on Rasayanika.com.

Job Title: Quality Control Specialist

Department– Clinical Trial Supply Management

Location– Lambda

No.of posts: 01

Eligibility: Bachelors degree in Pharmacy, Chemistry, Biology, or related field with 8+ years GMP related experience, or Masters degree in related field with 4+ years related experience in QA or QC and/or regulated environment highly preferred cGMP

Minimum Work Experience:
Great Experience in clinical trial supply or related Pharmaceutical or clinical trial research field ISO experience a plus  Subject Matter Expert in GMP production, Primary and Secondary packaging, SOPs and FDA, and other regulatory compliance regulations and standards.

Skills, Knowledge and Ability Requirements Mandatory:

• Excellent problem-solving skills; ability to resolve issues effectively and efficiently.
• Establishing and maintaining cooperative working relationships with others.
• Maintaining complete, accurate and organized records.
• Reading, understanding and complying with current Company policies and procedures including safety rules and regulations.
• Communicating clearly and concisely, both orally and in writing.
• Ability to work independently and to handle a variety of tasks simultaneously
• Knowledge of Microsoft Word, Excel, Outlook and PowerPoint

Position Summary:

We are looking for a Quality Control specialist responsible for developing and implementing a compliant and effective quality system for driving results in a fast-paced environment by effectively performing activities of significant variety and complexity to ensure quality and compliance with quality standards, SOPs and applicable ICH-GxP* applicable regulatory requirements needed for a clinical trial supply division.

Primary Duties and Responsibilities:

• Quality Assurance responsibilities include but are not limited to CGMP documentation review related to product release, facilities and equipment, material controls, packaging and labeling, and production & process controls.
• Responsible for the quality of documentation (control, retention, and archival) to support CGMP activities
• Responsible for product release activities per CGMP requirements
• Responsible for reporting quality system issues to the Head of the Department. This includes timely escalation of discrepancies upon identification.
• Perform change control, document control, vendor qualification, CAPA, IQ, OQ, PQ, sop, regulatory audits, internal audits, customer audits, vendor audits, validation, document review, QMS, training, batch release, recall/complaint handling.
• Fulfill all the legal regulatory requirements, set forth by the Ministry of Health, Maintain and assure compliance with applicable ICH, GMP and Good Clinical Practices, local regulatory affairs, legal Requirements, and Standard Operating Procedures (or any other as required).
• QC all the activities performed such as reception, storage, production, labeling, Printing, shipment, etc. are in accordance with the SOPs, previously established.
• Approval of BMR / BPR and related documents on day to day basis.
• Provides input into development of documents including master labels for study medication, manuals and quality documentation.
• Supervise, coach and train depot staff.
• Performs quality review and approval of other documents, protocols, SOPs and/or reports.
• Performs complex quality floor audits and/or floor inspections.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Support technical writing program initiatives such as development of document templates, technical writing workflows, etc.
• Provide customer service to all employees needing assistance with controlled documentation.
• Interact with other departments to eliminate quality system backlog
• Collate Annual Product Review data on a monthly basis\
• Conduct training of the Change Control and Document management systems

Apply Online

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