Apotex Inc., founded in 1974, is the largest Canadian-owned pharmaceutical company. We employ over 6,000 people worldwide in research, development, manufacturing, and distribution. We produce more than 300 generic pharmaceuticals in approximately 4,000 dosages and formats and export to over 115 countries around the globe.
Post: Team Leader-Quality R&D in Pharmaceutical Company
Job description
- Ensures that assigned work is performed in accordance with GxP, SOPs, regulatory requirements, best practices and established safety standards as applicable.
- Performs audits (both project and non-project related) or coordinates during audits to assure the compliance to GxP, SOPs and regulatory requirements of the following departments wherever applicable; Formulation Development, Product Evaluation and Analytical Support, Analytical Research Development, Quality Assurance Unit, and Other general divisional operations.
- Coordinate with team members for appropriate follow-up during any unresolved issues as a result of review findings.
- Conducts Internal Audits whenever required
- Develops, revises, implements, and maintains records of Standards Operating procedures and additional relevant documents for the Facility.
- Assigns QA personnel for audits and other QA unit duties directly and receives reports/updates from them with respect to status and progress, problems, issues of non-compliance with SOPs and GxP. Oversees the preparation of audit reports, including final review and QA Unit approval.
- Conducts Quality and Standards Operating Procedures training for the new & existing employees.
- Works constructively and pro-actively with other R&D departments to promote/ensure the efficient and effective operation.
- Recruit, train, develop and manage effectively the ongoing performance of their direct reports, which includes, but is not limited to:
1. Ensuring their Job Descriptions are reviewed, signed and sent to Employee Services, annually
2. Reviewing and updating employee development plans, ensuring that all employees are properly trained and qualified to execute their duties,
3. Providing coaching, feedback and recognition.- -
- Responsible to ensure compliance of team members (direct reports) with Safety and Employment policies (e.g., Respect in the Workplace – Prevention of Violence and/or Harassment).
- Routine monitoring of all functional areas to ensure adherence to the SOPs.
- Review of qualification/validation documents of instruments and equipment.
- Review of executed exhibit batch records & log books.
- To review various documents like Validation/stability protocols, Validation reports, Specifications, Method of analysis, Analytical reports etc. for the analytical support to Analytical Laboratory and Product Evaluation and Analytical Support Laboratory
- Issuance and Documentation for Method Validation related documents. Co-ordination with different laboratories for technology transfer related activities.
- Responsible for review or Authorizing/Approving of Out of specification (OOS) investigation and reporting, change controls, deviations and quality incident reports, LIR, CCR, AQRS and DR’s.
- Review of in-house and external calibration documents.
- Preparation for regulatory audits and making the compliance for the same.
- Co-ordination for periodic self-inspection for evaluation of the effectiveness of the quality systems.
- Co-ordination & ensuring timely execution of in-process activities for manufacturing & packaging.
- Coordination for performing gap assessment of Global Policies and Global SOPs.
- Works as a member of a team to achieve all outcomes.
- Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- Reports to Senior Manager R & D Quality with respect to the strategic/tactical planning, operational status and disposition of all matters relating to the operations in the QA unit.
- All other duties as assigned.
Desired Qualification:
Minimum Master Degree in Pharmacy or Master Degree in science
Experience & Skills:
Minimum of 8 years relevant experience in the pharmaceutical industry.
Experience in GxP (cGMP & cGLP) along with strong understanding of compliance in these areas
Additional Information:
Experience: Min. 8 years
Qualification: M.Pharm, M.Sc
Location: Bangalore
Functional Area: R&D
Industry Type: Pharma
Employment Type: Full Time
Job Type: Regular
End Date: 30th August, 2015
Interested candidates please share your resumes to vkeshri@apotex.co.in
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