Immacule is a research-based pharmaceutical company, which is a joint venture between SRS Pharmaceuticals Pvt. Ltd. and Acme Formulation Pvt. Ltd. Based in India, the two companies together have a robust product portfolio spread over major therapeutic areas, particularly Cardiovascular Drugs, Anticancer Drugs, Anti-Retroviral, Antibiotics, Anti Tubercular Medication, and Analgesics & Antipyretics.
Job Title : Manager - Microbiologist
Job Description :
Responsible for managing Microbiology department which meets production and regulatory requirement of Injectable /Lyophilized Plant.
- Should have exposure towards following test to be conducted in micro department
* Sterility test.
* LAL test.
* PW/ WFI testing and validation
* Different Sterility techniques.
* Sampling process.
* Chromatographic Techniques.
* Operation & Calibration of Instruments.
* Other Microbiology lab. Practice.
* Microbial limit test.
* Toxicity test.
- Monitoring of various quality trends.
- Should have good knowledge in GLP and responsible for its implementation.
- Investigations of batches for any failure and CAPA.
- Hands on experience in media fills according to PICS
- Knowledge on sterile area qualification as per c-GMP guidelines & equipment like autoclave, LAF, Filling/sealing lines validations from sterility and micro perspective.
- Should have knowledge of stability studies as per regulatory guidelines and its compliance
- Should be well versed with USFDA, MHRA, TGA and ANVISA guidelines.
- Strong leadership quality, Good interpersonal & training skill, Good oral communication & written skill.
Desired Profile :
Education and Experience : M. Sc / Ph. D Microbiology with relevant experience.
Skill Set :
- Experience of working with WHO GMP facility is must
- Exposure of working with USFDA, MHRA or any other stringent regulatory authorities will be an added advantage.
How to Apply :
Interested candidates can apply by sending their resumes to info@lyophilize.NET
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