BSc Pharmacy/Chemistry Job @ MSD - Quality Manager Post

e="text-align: center;">BSc Pharmacy/Chemistry Job @ MSD – Quality Manager Post

Dont forget to check out possible questions for this job below

MSD announces job opening for chemistry and pharmacy candidates. BSc Chemistry job opening 2023, BS Pharmacy job. Manager, External Quality post vacancy at MSD. MSD hiring chemistry and pharma candidates. Intrested and eligible candidates may check out all the details on the same below:

Job Title: Manager, External Quality

Location: Pune, Maharashtra, India

Elibgility Criteria:

Degree in Science, Engineering or any relevant technical discipline (BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent preferred).

Previous experience in the pharmaceutical industry with some knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred, for a minimum of 1- 2 years.

Skill & Competencies needed:

  • Solves range of straight forward problems
  • Receives moderate level of guidance and direction.
  • Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goal.
  • Responds to non-standard requests from clients and/or customers; investigations with assistance from others as needed.
  • Explains information and persuades others in straightforward situations.
  • Accountable for technical contribution to project team or sub-team; may manage/lead a small project team.
  • Ability to work across boundaries, developing interpersonal, relationship building and leadership ​skills.
  • Communicates easily in English and Chinese, both verbally and in writing, in support of the External Manufacturer sites associated with this role.
  • Knowledge of External Manufacturing Management, Supply Chain, Operations
  • Experience with COMET SAP is preferable.
  • Experience with batch record review and batch release process
  • Previous experience in audit support and deviation management

Job Description

EXTERNAL QUALITY ASSURANCE – PRODUCT QUALITY MANAGER – Specialist

The Product Quality Manager is responsible for ensuring that all products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with company expectations and all applicable regulatory requirements. Role has primary batch release responsibility and ensures that effective and robust Quality Systems are in place to comply with required regulations, policies and guidelines governing the External Party manufacture and release of API intermediates and APIs by means of risk-based quality oversight and on-site supervision, as appropriate.

What you will do:

  • Bring energy, knowledge, innovation and leadership to carry out the following:
  • Evaluate and/or release products to other sites with the assurance that the goods were produced in conformance to all applicable policies, procedures and compliance with all governing regulations; review and approve changes to master batch record.
  • Manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Finding
  • Provide support for audits of External Party by internal audit teams and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are implemented.
  • Conduct routine analytical change requests and support process modification change controls.
  • Annual Product Review Assembly
  • Provide support in the preparation of metrics, procedures and Quality Agreements
  • Provide proactive support to initiate quality improvement projects.
  • Track and monitor operational and quality performance of the External Manufacturer/ partner, responsible for shipment under quarantine.
  • Assist shipments of reference standards to External Manufacturer sites
  • Support routine process validation
  • Prepare pre-PAI assessments, support document requests for regulatory filings and post approval changes.
  • Occasional site visits to build relationships and monitor efforts to improve the External Manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums.

Apply Online

Important Questions and Answers for the above job role:

  1. What are the eligibility criteria for the Manager, External Quality post at MSD?

Answer: The eligibility criteria for this post include a degree in Science, Engineering, or any relevant technical discipline, with a preference for BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent. The candidate should also have previous experience in the pharmaceutical industry with some knowledge of Quality Systems, Quality Assurance, and Quality Control, including global GMP Quality Systems and regulatory requirements for a minimum of 1-2 years.

2. What are the main responsibilities of the Product Quality Manager in External Quality Assurance?

Answer: The Product Quality Manager is responsible for ensuring that all products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with company expectations and all applicable regulatory requirements. The role includes primary batch release responsibility and ensures that effective and robust Quality Systems are in place to comply with required regulations, policies, and guidelines governing the External Party manufacture and release of API intermediates and APIs by means of risk-based quality oversight and on-site supervision, as appropriate.

3. What skills and competencies are required for this position?

Answer: The ideal candidate should be able to solve a range of straightforward problems, receive a moderate level of guidance and direction, apply team effectiveness skills, listen and integrate diverse perspectives from across the work group, contribute and add value to the achievement of team goals, respond to non-standard requests from clients and/or customers, explain information and persuade others in straightforward situations, be accountable for technical contribution to project team or sub-team, work across boundaries, developing interpersonal, relationship building, and leadership skills, communicate easily in English and Chinese, both verbally and in writing, in support of the External Manufacturer sites associated with this role. The candidate should also have knowledge of External Manufacturing Management, Supply Chain, Operations, experience with COMET SAP, batch record review and batch release process, previous experience in audit support and deviation management.

4. What are the main tasks that the Product Quality Manager will perform in this role?

Answer: The Product Quality Manager will perform a range of tasks in this role, including evaluating and/or releasing products to other sites with the assurance that the goods were produced in conformance to all applicable policies, procedures, and compliance with all governing regulations, review and approve changes to master batch record, manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Finding, provide support for audits of External Party by internal audit teams and regulatory agencies, review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are implemented, conduct routine analytical change requests and support process modification change controls, prepare pre-PAI assessments, support document requests for regulatory filings and post-approval changes, and occasionally visit sites to build relationships and monitor efforts to improve the External Manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums.

5. What are the main challenges that the Product Quality Manager may face in this role?

Answer: The main challenges that the Product Quality Manager may face in this role include ensuring compliance with regulatory requirements, policies, and guidelines governing the External Party manufacture and release of API intermediates and APIs, managing routine deviations and complaints, coordinating significant investigations, providing support for audits of External Party by internal audit teams and regulatory agencies, ensuring appropriate and timely corrective actions are implemented, conducting routine analytical change requests and supporting process modification change controls, preparing pre-PAI assessments, supporting document requests for regulatory filings and post-approval changes, and building relationships and monitoring efforts to improve the External Manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums. The candidate should be able to demonstrate their ability to overcome these challenges based on their previous experience and skills.

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