Senior Manager/Manager - Microbiology - Pharma

We have an urgent opening for Senior Manager/ Manager - Microbiology in Nalagarh (Himachal) with our clients who are an integrated pharmaceutical company offering products to the global market. Headquartered at Gurgaon and plant in North India, the Company develops, manufactures and markets a wide range of quality products in diverse area of treatment. It is ranked second in the healthcare industry as Best place to Work for by GPTW Survey, 2016.

Summary Of The Overall Job :

To be responsible for planning and organizing, routine activities of the Quality Control Microbiology and laboratory functions to ensure the safety and reliability of products produced in compliance with Quality and various regulatory requirements.

Key Result Areas :

- On time testing of samples of finished product and raw materials

- On time Environment Monitoring in the Manufacturing areas

- On time reports on microbiological tests, any excursions, OOS and metrics.

- Adherence to Good Manufacturing Practices (GMP), SOP and Ensure Finished Products are free

- Regulatory Requirements

- On time review of Documentation from Pathogen

- Appropriate documentation of Investigations Microorganism

Key Functions / Responsibilities :

Compliance :

- To ensure that microbiological testing is performed in QA requirements. To ensure shifts and tests are scheduled so that required tests are performed on time and the results are provided on time.

- To be on top of compliance with respect to regulatory requirements, to interpret applicable quality and regulatory requirements and develop associated policies for the laboratories operations.

- To continuously investigate and trend invalid and Out-of-Specification results.

- To ensure appropriate and timely corrective actions are implemented.

- To work collaboratively with manufacturing and product development teams to improve quality, increase efficiency, and solve problems.

- To evaluate external audit observations and develop responses and oversight for related action plans.

- To interact with Manufacturing and R&D team and lead for qualification or validation projects at the plant.

- To ensure all established laboratory, regulatory, safety, and environmental procedures are followed.

- To adhere to the standards of quality as per GMP, company Quality Policies and site SOPs standards.

- To ensure routine data entry and data trend analysis reports are performed as defined.

- To identify excursions, OOS, Deviations and report possible preventative and corrective actions.

- To ensure good documentation practices in all aspects and phases of the work; provide reports for review in a timely manner; work with other lab personnel on projects and participate in (OOS) Out-of Specification and failure investigations.

- To maintain the safety and orderliness of the lab; apply knowledge of cGMPs and GLPs on a daily basis.

- To support Internal Audit Program and participate for the Customer and Regulatory Audits and follow up on and close the CAPAs on time.

Others :

- To provide training on laboratory methods and the team members.

- To ensure QC documentation and data trending activities.

Team Management :

- To guide and mentor the associates.

- To review their performance on regular basis and provide feedback for improvement

Education And Experience :

Education : Master in Microbiology

Experience : 15 years + in Microbiology in Pharmaceutical Industry