Symbiotec - Site Quality Head

Symbiotec Pharmalab Pvt. Ltd.

Date: 2 weeks ago

City: Ujjain, Madhya Pradesh

Contract type: Full time

Job To ensure preparation, review and approval of all procedures, in line with the regulatory guidelines/ expectations, identify the gaps and update the procedure.

To handle the day today changes, deviations, incidents, market complaints, OOS, OOT are investigated in line with regulatory expectations in time bound fashion.
To develop second line personnel's by training the operating level and supervisors /reporting authorities to evaluate and implement the risk and science-based approach in decision making.
To coordinate with different functions like R&D, production, engineering, RA, purchase, compliance, marketing etc.
To bring about a robust system to ensure that it meets the regulatory.
Ensure that the analytical tech transfer is a well planned process and successful at the site.
To conduct training for all technical staff, inculcate the culture of quality and compliance, and have the schedules adhered to as per the training calendar.
To host the audits by customers and regulatory authorities.
To provide regulatory / customer audit response in conjunction with corporate quality and deep track on the CAPA's for time bound closures.
To be actively involved in all investigations related to the quality issues at the site, to help the marketing team and the customers get the required technical clarifications in a timely manner, etc.
To identify, understand and evaluate the need for infrastructural requirements and to organize for the timely procurement of such requirements to improve the efficiency and effectiveness of the quality functions.
To derive mechanism for measurement of productivity and achieve organizational goal of QA&QC.
To ensure all marketing requests are responded to in a timely manner.
To track and update closure of all quality notifications in a timely manner.
To ensure quality trends of products are prepared and reviewed in timely.
To ensure all regulatory queries related to analytical validation are responded to in a timely manner.
To ensure all qualification and Validations are successfully carried out as per schedule.
To ensure Annual Product Review is prepared and approved in a timely manner.
To steer and participate Quality Management review of Level-1 and level-2 at site.
To participate in Quality Management review level-3 and present it to the top Management.
Preferable candidate should be from Biotech/ Pharmaceutical API industry only.

(ref:iimjobs.com)

How to apply

To apply for this job you need to authorize on our website. If you don't have an account yet, please register.

Post a resume

Similar jobs

Digital Marketing Executive (E-Commerce)

LeadsPanda, Ujjain, Madhya Pradesh

17 hours ago

Job Type- Full TimeLocation- UjjainJob OverviewThe Digital Marketing Executive will oversee the daily operations of online stores, ensuring a smooth and efficient shopping experience for customers. This role involves managing product listings, inventory, customer service, and optimizing the website's performance to drive sales and improve customer satisfaction. The ideal candidate should have a strong background in e-commerce, possess excellent communication...

SC QC Coordinator

PepsiCo, Ujjain, Madhya Pradesh

1 week ago

OverviewThe position will take care of Implementing of GLP, SOP’S, develop process control check sheets and its compliance, over all Lab equipment management and acting as site Sensory and Micro leader for the site. Postion is also responsible for RM, FG Testings, approvals and documentations.ResponsibilitiesLead site Sensory panel team capable & deliver right sensory for Raw material & FG.Ensure compliance...

Area Manager - Tractor Finance

Bajaj Finserv, Ujjain, Madhya Pradesh

4 weeks ago

Location Name: UjjainJob PurposeTo set up entire distribution which includes sales team, Dealer network & used tractor DSA and brokers for the region & Achieve MoM business sales targets & also manage Collections and PDD.Duties And Responsibilities Creating Distribution and Business Delivery Last mile(SM) hiring Setting up new dealer network Month on month business delivery Setting up DSA network Market...